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Heart FailurePhase 3PITCH-HFNCT01910389

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

A Phase 3 study testing Tadalafil in people with Heart Failure and Pulmonary Hypertension, run by Carelon Research at 63 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) <0.40, and… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Heart Failure, Pulmonary Hypertension
What is being tested?
Tadalafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
63 sitesin 2 countries
Study dates
Nov 2013to Feb 2014
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female age 21 years or older.
  • NYHA Class II-IV HF with LVSD (most recent LVEF < 0.40).
  • At high risk of future clinical instability, indicated by EITHER:
  • a hospitalization for the primary reason of decompensated HF within the 12 months prior to screening; OR a plasma B-type Natriuretic Peptide (BNP) level ≥ 300 pg/ml or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥1800pg/ml measured during a period of clinical stability in the 3 months prior to screening.
  • Documented secondary PH within the last 6 months
  • Medication and device treatment according to current American Heart Association/American College of Cardiology (AHA/ACC) guidelines.
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  • Stable medical therapy for 30 days prior to randomization
  • African-American patients intolerant of or otherwise unable or unwilling to utilize isosorbide dinitrate/hydralazine therapy will be included.
  • Willingness to comply with protocol, attend follow-up appointments, complete all study assessments and provide written informed consent.

Who cannot join

  • Concurrent or anticipated nitrate use for any reason, or nitrate use within the 14 days prior to screening through the day of randomization.
  • Known allergy, hypersensitivity (anaphylaxis), or adverse reaction to tadalafil or other Phosphodiesterase Type 5 (PDE5) inhibitor
  • Erectile dysfunction treated with a PDE5 inhibitor.
  • Severe renal dysfunction defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m^2 or requiring chronic dialysis
  • Current use of alpha antagonists (except carvedilol or tamsulosin) or use of cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, or cimetidine). Patients who have used a protease inhibitor that is a P450 3A4 inhibitor for longer than one week can be enrolled.
  • Pulmonary arterial hypertension (World Health Organization (WHO) Group I, III-V) for which PDE5 inhibitor therapy may be indicated
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  • Severe pulmonary disease requiring home oxygen therapy
  • Comorbidities including clinically significant valvular stenosis (aortic valve area < 0.8 cm^2 or a mitral valve area <1.0 cm^2), uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg) or hypotension (systolic blood pressure <85 mmHg)
  • Chronic intravenous inotrope therapy
  • Non-arteritic anterior ischemic optic neuropathy (NAION)
  • ST elevation MI (STEMI) within 90 days prior to screening
  • Coronary Artery Bypass Grafting (CABG) or mitral valve surgery, initiation of cardiac resynchronization (CRT) or initiation of β-blocker therapy within the 6 months prior to screening
  • Infiltrative or inflammatory myocardial disease (e.g. amyloid, sarcoid)
  • Heart transplant recipient
  • United Network Organ Sharing (UNOS) status 1A or 1B
  • Mechanical circulatory support (MCS) use or planned MCS use at time of consent
  • Active malignancy (except non-melanoma skin cancer) requiring therapy other than observation.
  • Severe non-cardiac illness resulting in life expectancy judged less than three years
  • Known chronic hepatic disease defined as aspartate aminotransferase (AST) and alanine transaminase (ALT) levels > 3.0 times the upper limit of normal
  • Inability to walk even a few steps due to non-cardiac (e.g. orthopedic) reasons
  • Participation in any clinical trial within the last 30 days (with exception of observational study)
  • Previous randomization in PITCH-HF

Trial locations and contacts

63 sites in 2 countries.

63 sites in 2 countries

United States62 sites

  • University of Michigan Health System

    Ann Arbor, Michigan

  • Maine Research Associates

    Auburn, Maine

  • University Cardiology Associates LLC

    Augusta, Georgia

  • Primary Care Cardiology Research, Inc.

    Ayer, Massachusetts

  • Johns Hopkins Hospital

    Baltimore, Maryland

  • Brigham and Women's Hospital

    Boston, Massachusetts

  • Massachusetts General Hospital

    Boston, Massachusetts

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey

  • New York Methodist Hospital

    Brooklyn, New York

  • Northwestern University

    Chicago, Illinois

  • University of Illinois Hospital

    Chicago, Illinois

  • The Lindner Center for Research & Education at The Christ Hospital

    Cincinnati, Ohio

  • Cleveland Clinic

    Cleveland, Ohio

  • Missouri Cardiovascular Specialists

    Columbia, Missouri

  • CIVA/CArdiovascular Research Institute of Dallas

    Dallas, Texas

  • Dayton VA Medical Center

    Dayton, Ohio

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan

  • Henry Ford Hospital

    Detroit, Michigan

  • Essentia Health East

    Duluth, Minnesota

  • Eisenhower Army Medical Center

    Fort Gordon, Georgia

  • Broward Health

    Fort Lauderdale, Florida

  • Allianz Medical and Research Center

    Fountain Valley, California

  • Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina

  • Hackensack University Medical Center

    Hackensack, New Jersey

  • Michael E. Debakey VA Medical Center

    Houston, Texas

  • Heart Center Inc - Research

    Huntsville, Alabama

  • Glacier View Research Institute

    Kalispell, Montana

  • St. Luke's Health System

    Kansas City, Missouri

  • Lancaster Heart and Stroke Foundation

    Lancaster, Pennsylvania

  • Baptist Health Transplant Institute

    Little Rock, Arkansas

  • Baptist Hospital East

    Louisville, Kentucky

  • Miller School of Medicine University of Miami

    Miami, Florida

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin

  • Metropolitan Heart and Vascular Institute

    Minneapolis, Minnesota

  • LSU Health Sciences Center

    New Orleans, Louisiana

  • Columbia University Medical Center

    New York, New York

  • Mount Sinai Medical Center

    New York, New York

  • Christiana Care Health System

    Newark, Delaware

  • Newark Beth Israel Medical Center

    Newark, New Jersey

  • Oklahoma City VA

    Oklahoma City, Oklahoma

  • Orlando Health

    Orlando, Florida

  • Research Integrity LLC

    Owensboro, Kentucky

  • Methodist Medical Group Cardiology

    Peoria, Illinois

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania

  • Temple University

    Philadelphia, Pennsylvania

  • Charlotte Heart Group Research Center

    Port Charlotte, Florida

  • Mayo Clinic

    Rochester, Minnesota

  • Brevard Cardiovascular Research Associates

    Rockledge, Florida

  • William Beaumont Hospital

    Royal Oak, Michigan

  • Covenant Center for the Heart

    Saginaw, Michigan

  • University of Utah

    Salt Lake City, Utah

  • Cardiology Associates of Schenectady

    Schenectady, New York

  • Grand View - Lehigh Valley Health Service

    Sellersville, Pennsylvania

  • Heart & Vascular Center of NJ/Cardio Metabolic Institute

    Somerset, New Jersey

  • Stony Brook University Hospital

    Stony Brook, New York

  • SUNY Upstate Medical University

    Syracuse, New York

  • Bronx - Lebanon Hospital Center

    The Bronx, New York

  • Warren Cancer Research Foundation

    Tulsa, Oklahoma

  • MGH West

    Waltham, Massachusetts

  • Aspirus Wausau Hospital

    Wausau, Wisconsin

  • Lankenau Medical Center

    Wynnewood, Pennsylvania

Other trials in United States

Canada1 site

  • Jewish General Hospital

    Montreal, Quebec

Other trials in Canada

About this study

This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.

Being tested
Tadalafil, Placebo for tadalafil
Keywords
Heart failure, Pulmonary hypertension, tadalafil, Phosphodiesterase Type 5 Inhibition
Medical subject headings
Heart Failure, Hypertension, Pulmonary

What participants receive

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

  • TadalafilDrug

    Also called Adcirca

  • Placebo for tadalafilDrug

Study groups in NCT01910389
Study groupRoleWhat they receive
TadalafilActive comparatorTadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
Receives: Drug: Tadalafil
PlaceboPlacebo comparatorPlacebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
Receives: Drug: Placebo for tadalafil

What is being measured

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

  1. Composite Outcome of Cardiovascular (CV) Mortality or Heart Failure (HF) Hospitalization

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject

Secondary outcomes (12)

  1. Cardiovascular Mortality

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject

  2. Heart Failure Hospitalization

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject

  3. All-cause Mortality

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject

  4. Composite Outcome of All-cause Mortality or CV Hospitalization (Myocardial Infarction, Acute Coronary Syndrome, Stroke, Arrhythmia, or Heart Failure)

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject

  5. Frequency of CV Hospitalizations

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject

  6. Frequency of HF Hospitalizations

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject

  7. Change in 6 Minute Walk Distance From Baseline to 3 Months

    Measured: Randomization to 3 months

  8. Change in MLHFQ Score From Baseline to 3 Months

    Measured: Randomization to 3 months

  9. Change in 6 Minute Walk Distance From Baseline to 18 Months

    Measured: Randomization to 18 months

  10. Trend in 6 Minute Walk Distance From Baseline Through 18 Months

    Measured: Randomization to 18 months

  11. Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline to 18 Months

    Measured: Randomization to 18 months

  12. Trend in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline Through 18 Months

    Measured: Randomization to 18 months

Timeline

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

  1. First posted29 Jul 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Why it stopped: terminated by funding agency

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01910389
Sponsor's protocol ID
U01HL105463
Acronym
PITCH-HF
Status last verified
Jan 2014
First submitted
25 Jul 2013
Last updated
4 May 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tadalafil in people with Heart Failure and Pulmonary Hypertension, run by Carelon Research at 63 sites in 2 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 9 inclusion and 22 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: stopped early, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Canada. 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 4 May 2015). 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?

Composite Outcome of Cardiovascular (CV) Mortality or Heart Failure (HF) Hospitalization (time frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject). 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 NCT01910389.

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 4 May 2015.

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