Congestive Heart FailurePhase 3NCT00095238

Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

A Phase 3 study testing Irbesartan in people with Congestive Heart Failure, run by Bristol-Myers Squibb at 229 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Congestive Heart Failure
What is being tested?: Irbesartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4,128 participants
Where: 229 sitesin 25 countries
Study dates: Jun 2002to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
Left ventricular ejection fraction (LVEF) > = 45%
Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.

Who cannot join

Acute myocardial infarction within 3 months;
Heart revascularization procedure within 3 months;
Hospitalization for angina within 3 months;
Other heart surgery
Life-threatening or uncontrolled arrhythmia
Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months;

Show all 13Show fewer

Stroke or surgery of the arteries in the brain within 3 months;
Serious lung disease which requires use of home oxygen.
Significantly low blood pressure
Significantly high blood pressure
Other known diseases that may limit life expectancy to <3 years;
Known or suspected bilateral kidney artery narrowing;
Geographic or social factors making study participation and follow-up impractical.

Trial locations and contacts

229 sites in 25 countries.

Country

City, postcode or hospital

229 sites in 25 countries

United States60 sites

Local Institution
Albany, New York
Local Institution
Albuquerque, New Mexico
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Auburn, Maine
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Austin, Texas
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Birmingham, Alabama
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Boston, Massachusetts
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Canton, Ohio
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Chalmette, Louisiana
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Chicago, Illinois
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Cincinnati, Ohio
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Columbus, Ohio
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Concord, North Carolina
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Detroit, Michigan
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Durham, North Carolina
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East Syracuse, New York
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Elmer, New Jersey
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Farmington, Connecticut
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Flourtown, Pennsylvania
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Flushing, New York
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Germantown, Tennessee
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Haverhill, Massachusetts
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Jacksonville, Florida
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Jacksonville Beach, Florida
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Jeffersonville, Indiana
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Lake Worth, Florida
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Lancaster, Pennsylvania
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Lebanon, New Hampshire
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Little Rock, Arkansas
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Lorain, Ohio
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Los Angeles, California
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Louisville, Kentucky
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Lynchberg, Virginia
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Madison, Wisconsin
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Minneapolis, Minnesota
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Natick, Massachusetts
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Omaha, Nebraska
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Peoria, Arizona
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Peoria, Illinois
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Petoskey, Michigan
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Portland, Oregon
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Reno, Nevada
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Richmond, Virginia
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Rochester, New York
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San Diego, California
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San Francisco, California
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Sandusky, Ohio
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Shreveport, Louisiana
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South Boston, Virginia
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Spokane, Washington
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St Louis, Missouri
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Takoma Park, Maryland
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Tampa, Florida
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The Bronx, New York
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Towson, Maryland
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Troy, New York
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Tucson, Arizona
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Vero Beach, Florida
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Winston-Salem, North Carolina

Other trials in United States

Netherlands20 sites

Local Institution
Alkmaar
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Almere Stad
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Amersfoort
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Apeldoorn
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Assen
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Breda
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Delft
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Emmen
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Gorinchem
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Groningen
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Heemstede
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Helmond
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Hengelo Ov
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Nijmegen
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Rotterdam
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Sittard
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Sneek
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Veldhoven
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Vlaardingen
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Zaandam

Other trials in Netherlands

France17 sites

Local Institution
Abbeville
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Cholet
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Dax
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Gap
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Langres
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Lille
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Montbéliard
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Paris
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Poissy
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Pontoise
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Provins
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Roubaix
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Rouen
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St-Malo
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Tours
Local Institution
Vandœuvre-lès-Nancy
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Vichy

Other trials in France

Germany16 sites

Local Institution
Bad Homburg
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Berlin
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Göttingen
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Gunzenhausen
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Halle
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Homburg / Saar
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Jena
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Langen
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Leipzig
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Mainz
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Marburg
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München
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Regensburg
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Stuttgart
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Witten
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Würzburg

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Canada12 sites

Local Institution
Ajax, Ontario
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Calgary, Alberta
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Hamilton, Ontario
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Longueuil, Quebec
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Montreal, Quebec
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Rexdale, Ontario
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Saint-Lambert, Quebec
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Scarborough Village, Ontario
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Ste-Foy, Quebec
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Toronto, Ontario
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Victoria, British Columbia
Local Institution
Weston, Ontario

Other trials in Canada

Australia11 sites

Local Institution
Auchenflower, Queensland
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Brisbane, Queensland
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Coffs Harbour, New South Wales
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Concord, New South Wales
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Garran, New South Wales
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Geelong, Victoria
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Kogarah, New South Wales
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Launceston, Tasmania
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Prahran, Victoria
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Randwick, New South Wales
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Woolloongabba, Queensland

Other trials in Australia

Italy11 sites

Local Institution
Ascoli Piceno
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Bologna
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Brescia
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Cosenza
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Pavia
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Perugia
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Piacenza
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Roma
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Siena
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Trieste
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Udine

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Spain10 sites

Local Institution
A Coruña
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Barcelona
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Córdoba
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Madrid
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Málaga
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Murcia
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Palma de Mallorca
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Seville
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Valencia
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Zaragoza

Other trials in Spain

Belgium9 sites

Local Institution
Aalst
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Aye
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Borgerhout
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Genk-waterschei
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Ghent
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Hasselt
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Huy
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Leuven
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Verviers

Other trials in Belgium

Sweden7 sites

Local Institution
Falun
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Gothenburg
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Linköping
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Malmö
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Skellefteå
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Stockholm
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Sundsvall

Other trials in Sweden

Argentina6 sites

Local Institution
Buenos Aires, Buenos Aires
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Córdoba, Córdoba Province
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Corrientes, Corrientes Province
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Mendoza, Mendoza Province
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Rosario, Santa Fe Province
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San Martín, Buenos Aires

Other trials in Argentina

Brazil6 sites

Local Institution
Belo Horizonte, Minas Gerais
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Campinas, São Paulo
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Goiania-go, Goiás
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Rio de Janeiro, Rio de Janeiro
Local Institution
Salvador, Estado de Bahia
Local Institution
Sao Paulo, Sp, São Paulo

Other trials in Brazil

Poland6 sites

Local Institution
Bydgoszcz
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Katowice
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Piotrkow Tryb.
Local Institution
Stalowa Wola
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Warsaw
Local Institution
Wroclaw

Other trials in Poland

United Kingdom6 sites

Local Institution
Dundee
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Glasgow, Dumbartonshire
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Hull, Yorkshire
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Londonderry, Londonderry
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Romford, Essex
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York, Yorkshire

Other trials in United Kingdom

South Africa5 sites

Local Institution
Berea, KwaZulu-Natal
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Johannesburg, Gauteng
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KwaKhangela, KwaZulu-Natal
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Morningside, Gauteng
Local Institution
Parktown West, Gauteng

Other trials in South Africa

Hungary4 sites

Local Institution
Budapest
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Debrecen
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Siófok
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Szeged

Other trials in Hungary

Mexico4 sites

Local Institution
Aguascalientes, Aguascalientes
Local Institution
Guadalajara, Jalisco
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Mexico City, Mexico City
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San Pedro Garza García, Nuevo León

Other trials in Mexico

Norway3 sites

Local Institution
Baerum Postterminal
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Stavanger
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Tønsberg

Other trials in Norway

Russia3 sites

Local Institution
Moscow
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Saint Petersburg
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Saratov

Other trials in Russia

Switzerland3 sites

Local Institution
Bellinzona
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Liestal
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Zurich

Other trials in Switzerland

Czechia2 sites

Local Institution
Prague
Local Institution
Ústí nad Labem

Other trials in Czechia

Denmark2 sites

Local Institution
Copenhagen
Local Institution
Copenhagen Nv

Other trials in Denmark

Greece2 sites

Local Institution
Athens
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Pátrai

Other trials in Greece

Ireland2 sites

Local Institution
County Dublin, Dublin
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Dublin, Dublin

Other trials in Ireland

Portugal2 sites

Local Institution
Lisbon
Local Institution
Matosinhos Municipality

Other trials in Portugal

About this study

Conditions: Congestive Heart Failure
Being tested: Irbesartan, Placebo
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IrbesartanDrug
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
PlaceboDrug
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

Study groups in NCT00095238
Study group	Role	What they receive
1	Active comparator	Not described Receives: Drug: Irbesartan
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.
Measured: Year 1, Year 2, Year 3, Year 4, Year 5

Secondary outcomes (18)

Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
Treatment comparisons for time to heart failure mortality or heart failure hospitalization
Measured: Year 1, Year 2, Year 3, Year 4, Year 5
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Measured: Baseline, Month 6, Month 14
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Measured: Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.
Measured: Baseline, Month 6, Month 14
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.
Measured: Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
Treatment comparisons for time to cardiovascular death
Measured: Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing All-cause Death at Given Time Points
Treatment comparisons for time to all-cause death
Measured: Year 1, Year 2, Year 3, Year 4, Year 5
Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
NYHA functional classification=4-tiered system relating symptoms to everyday activities \& quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.
Measured: Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Measured: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Measured: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Measured: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Measured: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Measured: Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Measured: Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.
Measured: Year 1, Year 2, Year 3, Year 4, Year 5
Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Measured: Baseline, Month 6, Month 18, Month 30
Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Measured: Baseline, Month 42, Month 54, Month 66
Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.
Measured: Baseline, Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2002Jul 2008

First posted2 Nov 2004 (estimated)
Study startJun 2002
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 4,128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00095238
Sponsor's protocol ID: CV131-148
Status last verified: Mar 2015
First submitted: 1 Nov 2004
Last updated: 7 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
PubMed 19001508
Zile MR, Gaasch WH, Anand IS, Haass M, Little WC, Miller AB, Lopez-Sendon J, Teerlink JR, White M, McMurray JJ, Komajda M, McKelvie R, Ptaszynska A, Hetzel SJ, Massie BM, Carson PE; I-Preserve Investigators. Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial. Circulation. 2010 Mar 30;121(12):1393-405. doi: 10.1161/CIRCULATIONAHA.109.909614. Epub 2010 Mar 15.
PubMed 20231531
McMurray JJ, Carson PE, Komajda M, McKelvie R, Zile MR, Ptaszynska A, Staiger C, Donovan JM, Massie BM. Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial. Eur J Heart Fail. 2008 Feb;10(2):149-56. doi: 10.1016/j.ejheart.2007.12.010.
PubMed 18279770
Carson P, Massie BM, McKelvie R, McMurray J, Komajda M, Zile M, Ptaszynska A, Frangin G; I-PRESERVE Investigators. The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design. J Card Fail. 2005 Oct;11(8):576-85. doi: 10.1016/j.cardfail.2005.06.432.
PubMed 16230259
McKelvie RS, Komajda M, McMurray J, Zile M, Ptaszynska A, Donovan M, Carson P, Massie BM; I-Preserve Investigators. Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial. J Card Fail. 2010 Feb;16(2):128-34. doi: 10.1016/j.cardfail.2009.09.007. Epub 2009 Nov 4.
PubMed 20142024
Lassen MCH, Ostrominski JW, Claggett BL, Neuen BL, Beldhuis IE, Butt JH, Biering-Sorensen T, Desai AS, Lewis EF, Jhund PS, Mc Causland F, Anand IS, Pfeffer MA, Pitt B, Zannad F, Zile MR, McMurray JJV, Solomon SD, Vaduganathan M. Obesity and Risk of Kidney Outcomes in Heart Failure With Preserved Ejection Fraction: A Participant-Level Pooled Analysis of 4 Contemporary Trials. JACC Heart Fail. 2025 Aug;13(8):102498. doi: 10.1016/j.jchf.2025.03.042. Epub 2025 Jun 9.
PubMed 40494011
Kondo T, Campbell R, Jhund PS, Anand IS, Carson PE, Lam CSP, Shah SJ, Vaduganathan M, Zannad F, Zile MR, Solomon SD, McMurray JJV. Low Natriuretic Peptide Levels and Outcomes in Patients With Heart Failure and Preserved Ejection Fraction. JACC Heart Fail. 2024 Aug;12(8):1442-1455. doi: 10.1016/j.jchf.2024.04.027. Epub 2024 Jun 19.
PubMed 38904646
Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.
PubMed 37366061
Kondo T, Jering KS, Jhund PS, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Packer M, Petrie MC, Pfeffer MA, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Solomon SD, McMurray JJV. Predicting Stroke in Heart Failure and Preserved Ejection Fraction Without Atrial Fibrillation. Circ Heart Fail. 2023 Jul;16(7):e010377. doi: 10.1161/CIRCHEARTFAILURE.122.010377. Epub 2023 Jun 23.
PubMed 37350280
Curtain JP, Adamson C, Kondo T, Butt JH, Desai AS, Zannad F, Rouleau JL, Rohde LE, Kober L, Anand IS, van Veldhuisen DJ, Zile MR, Lefkowitz MP, Solomon SD, Packer M, Petrie MC, Jhund PS, McMurray JJV. Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. Eur Heart J. 2023 Feb 21;44(8):668-677. doi: 10.1093/eurheartj/ehac801.
PubMed 36632831
Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.
PubMed 33301080
Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.
PubMed 31370950
Kristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766.
PubMed 30871349
Kristensen SL, Mogensen UM, Jhund PS, Petrie MC, Preiss D, Win S, Kober L, McKelvie RS, Zile MR, Anand IS, Komajda M, Gottdiener JS, Carson PE, McMurray JJ. Clinical and Echocardiographic Characteristics and Cardiovascular Outcomes According to Diabetes Status in Patients With Heart Failure and Preserved Ejection Fraction: A Report From the I-Preserve Trial (Irbesartan in Heart Failure With Preserved Ejection Fraction). Circulation. 2017 Feb 21;135(8):724-735. doi: 10.1161/CIRCULATIONAHA.116.024593. Epub 2017 Jan 4.
PubMed 28052977
Gandhi PU, Chow SL, Rector TS, Krum H, Gaggin HK, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Carson PE, Januzzi JL Jr, Anand IS. Prognostic Value of Insulin-Like Growth Factor-Binding Protein 7 in Patients with Heart Failure and Preserved Ejection Fraction. J Card Fail. 2017 Jan;23(1):20-28. doi: 10.1016/j.cardfail.2016.06.006. Epub 2016 Jun 16.
PubMed 27317843

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See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Congestive Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
ClinicalTrials.gov ID: NCT00095238
Acronym / sponsor ID: CV131-148
Conditions: Congestive Heart Failure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,128 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Sanofi
Study start: Jun 2002
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 2 Nov 2004 (estimated)
Results: Posted 8 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Irbesartan
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
Left ventricular ejection fraction (LVEF) > = 45%
Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.

Key exclusion criteria (13 listed)

Acute myocardial infarction within 3 months;
Heart revascularization procedure within 3 months;
Hospitalization for angina within 3 months;
Other heart surgery
Life-threatening or uncontrolled arrhythmia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IrbesartanTablets, Oral, titration from 75 to 300 mg, once daily up to 6 years	Drug	1
PlaceboTablets, Oral, titration from 75 to 300 mg, once daily up to 6 years	Drug	2

Primary outcome

Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.

18 secondary outcomes

Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
Time frame: Baseline, Month 6, Month 14
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
Time frame: Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
Time frame: Baseline, Month 6, Month 14
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing All-cause Death at Given Time Points
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
Time frame: Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Time frame: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Time frame: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
Time frame: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
Time frame: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
Time frame: Baseline, Month 6, Month 18, Month 30
Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
Time frame: Baseline, Month 42, Month 54, Month 66
Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
Time frame: Baseline, Final Visit

Results and safety

Results posted to the registry on 8 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Irbesartan	2,067	1,210
Placebo	2,061	1,209

Primary outcome: Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints

Time frame: Year 1, Year 2, Year 3, Year 4, Year 5. Number. Unit: percentage of participants

Measure	Irbesartan n = 2067	Placebo n = 2061
Percentage at 1 Year	12.3	12.1
Percentage at 2 Years	20.7	21.3
Percentage at 3 Years	26.4	28.4
Percentage at 4 Years	32.9	34.2
Percentage at 5 Years	39.2	39.5

Population analysed: Randomized Participants

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs: from start of study through last treatment +30 days; AEs: through the last dose +1 day.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IRBESARTAN	1,146 of 2,064 (55.5%)	1,255 of 2,064 (60.8%)	Not reported
PLACEBO	1,155 of 2,062 (56%)	1,191 of 2,062 (57.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19001508Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
Results publication: PubMed 20231531Zile MR, Gaasch WH, Anand IS, Haass M, Little WC, Miller AB, Lopez-Sendon J, Teerlink JR, White M, McMurray JJ, Komajda M, McKelvie R, Ptaszynska A, Hetzel SJ, Massie BM, Carson PE; I-Preserve Investigators. Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial. Circulation. 2010 Mar 30;121(12):1393-405. doi: 10.1161/CIRCULATIONAHA.109.909614. Epub 2010 Mar 15.
Results publication: PubMed 18279770McMurray JJ, Carson PE, Komajda M, McKelvie R, Zile MR, Ptaszynska A, Staiger C, Donovan JM, Massie BM. Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial. Eur J Heart Fail. 2008 Feb;10(2):149-56. doi: 10.1016/j.ejheart.2007.12.010.
Results publication: PubMed 16230259Carson P, Massie BM, McKelvie R, McMurray J, Komajda M, Zile M, Ptaszynska A, Frangin G; I-PRESERVE Investigators. The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design. J Card Fail. 2005 Oct;11(8):576-85. doi: 10.1016/j.cardfail.2005.06.432.
Results publication: PubMed 20142024McKelvie RS, Komajda M, McMurray J, Zile M, Ptaszynska A, Donovan M, Carson P, Massie BM; I-Preserve Investigators. Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial. J Card Fail. 2010 Feb;16(2):128-34. doi: 10.1016/j.cardfail.2009.09.007. Epub 2009 Nov 4.
Derived from this study: PubMed 40494011Lassen MCH, Ostrominski JW, Claggett BL, Neuen BL, Beldhuis IE, Butt JH, Biering-Sorensen T, Desai AS, Lewis EF, Jhund PS, Mc Causland F, Anand IS, Pfeffer MA, Pitt B, Zannad F, Zile MR, McMurray JJV, Solomon SD, Vaduganathan M. Obesity and Risk of Kidney Outcomes in Heart Failure With Preserved Ejection Fraction: A Participant-Level Pooled Analysis of 4 Contemporary Trials. JACC Heart Fail. 2025 Aug;13(8):102498. doi: 10.1016/j.jchf.2025.03.042. Epub 2025 Jun 9.
Derived from this study: PubMed 38904646Kondo T, Campbell R, Jhund PS, Anand IS, Carson PE, Lam CSP, Shah SJ, Vaduganathan M, Zannad F, Zile MR, Solomon SD, McMurray JJV. Low Natriuretic Peptide Levels and Outcomes in Patients With Heart Failure and Preserved Ejection Fraction. JACC Heart Fail. 2024 Aug;12(8):1442-1455. doi: 10.1016/j.jchf.2024.04.027. Epub 2024 Jun 19.
Derived from this study: PubMed 37366061Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.
Derived from this study: PubMed 37350280Kondo T, Jering KS, Jhund PS, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Packer M, Petrie MC, Pfeffer MA, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Solomon SD, McMurray JJV. Predicting Stroke in Heart Failure and Preserved Ejection Fraction Without Atrial Fibrillation. Circ Heart Fail. 2023 Jul;16(7):e010377. doi: 10.1161/CIRCHEARTFAILURE.122.010377. Epub 2023 Jun 23.
Derived from this study: PubMed 36632831Curtain JP, Adamson C, Kondo T, Butt JH, Desai AS, Zannad F, Rouleau JL, Rohde LE, Kober L, Anand IS, van Veldhuisen DJ, Zile MR, Lefkowitz MP, Solomon SD, Packer M, Petrie MC, Jhund PS, McMurray JJV. Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. Eur Heart J. 2023 Feb 21;44(8):668-677. doi: 10.1093/eurheartj/ehac801.
Derived from this study: PubMed 33301080Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.
Derived from this study: PubMed 31370950Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.

Related trials for Congestive Heart Failure

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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

229 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irbesartan in people with Congestive Heart Failure, run by Bristol-Myers Squibb at 229 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, Netherlands, France, Germany, Canada and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints (time frame: Year 1, Year 2, Year 3, Year 4, Year 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00095238, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.