Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

An observational study of Heart Failure and Cohort Study, run by AstraZeneca at 103 sites in France.

Completed

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

Trial summary

The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution Read more about this study

Who is it for?: Any age
Conditions the study is for: Heart Failure, Cohort Study
What is being tested?: Candesartan
Type of treatment: Pill or oral medicine
How many people: 450 participants
Where: 103 sitesFrance
Study dates: Jan 2008to Jul 2010
Phase: Observational
Are there results?: None posted in the registry

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients seen in outpatient care (private consultation or outpatient hospital consultation) at the baseline visit

Who may be able to join

outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure

Who cannot join

patients included in a clinical trial the last 30 days before consultation
patients unable to answer the questions for linguistic or cognitive reasons
patients who will be difficult to follow during the one year study

Trial locations and contacts

103 sites in 1 country.

City, postcode or hospital

103 sites in 1 country

France103 sites

Research Site
Allauch, Provence
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Amiens, Picardie
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Annecy-le-Vieux, Dauphine
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Annemasse, Dauphine
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Apt, Vallee Du Rhone
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Arles, Languedoc
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Arpajon, Touraine
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Arras, Artois
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Aulnay-sous-Bois, Paris Nord Est
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Beauchamp, Vexin
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Beauvais, Vexin
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Besançon, Aube Franche Comte
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Béthune, Artois
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Béziers, Catalogne
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Bordeaux, Aquitaine Nord
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Boulogne-Billancourt, Hauts de Seine
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Bourgoin, Lyonnais
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Bron, Lyonnais
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Bry-sur-Marne, Brie
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Caen, Basse Normandie
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Castanet-Tolosan, Midi Pyrenees
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Castelsarrasin, Gascogne
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Cergy, Vexin
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Chambray-lès-Tours, Touraine
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Château-d'Olonne, Charente
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Châteaubriant, Pays de Loire
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Châteaurenard, Vallee Du Rhone
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Chelles, Vexin
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Clermont-Ferrand, Auvergne Stephanois
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Cogolin, Maures Corse
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Condé-sur-l'Escaut, Picardie
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Creil, Vexin
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Dax, Aquitaine Sud
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Dijon, Bourgogne-Franche-Comté
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Dole, Bourgogne-Franche-Comté
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Épernay, Champagne Ardennes
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Évecquemont, Yvelines
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Gap, Vallee Du Rhone
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Gennevilliers, Yvelines
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Gleizé, Lyonnais
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Granville, Basse Normandie
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Hazebrouck, Flandres
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Hyères, Maures Corse
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La Source, Sologne
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Langres, Aube Franche Comte
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Lannion, Bretagne Nord
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Lille, Flandres
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Limoges, Limousin
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Lyon, Lyonnais
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Maisons-Laffitte, Yvelines
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Marseille, Provence
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Mayenne, Basse Normandie
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Meaux, Brie
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Montargis, Sologne
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Montauban, Gascogne
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Montfermeil, Paris Nord Est
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Montpellier, Languedoc
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Montreuil, Paris Nord Est
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Morlaix, Bretagne Sud
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Mulhouse, Alsace
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Muret, Midi Pyrenees
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Nancy, Lorraine
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Nantes, Pays de Loire
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Nice, Esterel
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Nîmes, Languedoc
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Niort, Charente
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Orléans, Sologne
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Paray-le-Monial, Bourgogne-Franche-Comté
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Paris, Paris Centre
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Périgueux, Gascogne
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Perpignan, Catalogne
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Poitiers, Charente
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Pontoise, Vexin
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Rennes, Bretagne Nord
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Rillieux-la-Pape, Lyonnais
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Rodez, Languedoc
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Rognac, Provence
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Rouen, Haute Normandie
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Royan, Charente
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Saint-Amand-Montrond, Limousin
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Saint-Avold, Lorraine
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Saint-Chamond, Auvergne Stephanois
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Saint-Etienne, Auvergne Stephanois
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Saint-Jean-de-Luz, Aquitaine Sud
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Saint-Martin-d'Aubigny, Basse Normandie
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Saint-Raphaël, Esterel
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Saint-Yrieix-la-Perche, Limousin
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Sallanches, Dauphine
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Salon-de-Provence, Provence
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Sarcelles, Vexin
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Savigny-sur-Orge, Brie
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Semur-en-Auxois, Bourgogne-Franche-Comté
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Sète, Catalogne
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Tarbes, Aquitaine Sud
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Tonnerre, Sologne
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Toulon, Maures Corse
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Tours, Touraine
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Valenciennes, Picardie
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Valognes, Basse Normandie
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Vesoul, Aube Franche Comte
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Villefranche-de-Rouergue, Languedoc
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Villiers-sur-Orge, Touraine
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Wattrelos, Flandres

Other trials in France

About this study

Conditions: Heart Failure, Cohort Study
Being tested: Candesartan
Keywords: candesartan, heart failure, cohort study, France
Medical subject headings: Heart Failure

What participants receive

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

CandesartanDrug
Also called Atacand
Oral tablets

Study groups in NCT00679640
Study group	Role	What they receive
1		Outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure Receives: Drug: Candesartan

What is being measured

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

Profile of patients treated with candesartan for heart failure
Measured: At inclusion

Secondary outcomes (3)

Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring
Measured: 6 and 12 months after
Percentage of patients stopping its treatment and reasons why
Measured: 12 months after
Percentage of hospitalisations due to heart failure and cardiovascular deaths
Measured: 12 months after

Timeline

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

Jan 2008Jul 2010

First posted19 May 2008 (estimated)
Study startJan 2008
Primary completionJun 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00679640
Sponsor's protocol ID: NIS-CFR-ATA-2007/1
Acronym: SISTOLA
Status last verified: Jul 2010
First submitted: 15 May 2008
Last updated: 2 Dec 2010
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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 Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France
ClinicalTrials.gov ID: NCT00679640
Acronym / sponsor ID: SISTOLA / NIS-CFR-ATA-2007/1
Conditions: Heart Failure, Cohort Study
Keywords: candesartan, heart failure, cohort study, France
Study type: Observational
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Takeda
Study start: Jan 2008
Primary completion: Jun 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 19 May 2008 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Drug: CandesartanOutpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients seen in outpatient care (private consultation or outpatient hospital consultation) at the baseline visit

Key inclusion criteria (1 listed)

outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure

Key exclusion criteria (3 listed)

patients included in a clinical trial the last 30 days before consultation
patients unable to answer the questions for linguistic or cognitive reasons
patients who will be difficult to follow during the one year study

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
CandesartanAlso: AtacandOral tablets	Drug	1

Primary outcome

Profile of patients treated with candesartan for heart failure
Time frame: At inclusion

3 secondary outcomes

Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring
Time frame: 6 and 12 months after
Percentage of patients stopping its treatment and reasons why
Time frame: 12 months after
Percentage of hospitalisations due to heart failure and cardiovascular deaths
Time frame: 12 months after

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2010.

Related trials for Heart Failure

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

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.

Stephane Bouee, MD, MSc principal investigator

CEMKA EVAL - Bourg La Reine - France

Luc Hittinger, MD, Prof study chair

Hôpital Henri Mondor - Service de cardiologie - Créteil - France

103 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Cohort Study, run by AstraZeneca at 103 sites in France.

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 1 inclusion and 3 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 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Profile of patients treated with candesartan for heart failure (time frame: At inclusion). 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 NCT00679640.

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 2 Dec 2010.