Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure (PITCH-HF)
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ClinicalTrials.gov Identifier: NCT01910389 |
Recruitment Status
:
Terminated
(terminated by funding agency)
First Posted
: July 29, 2013
Results First Posted
: May 4, 2015
Last Update Posted
: May 4, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure Pulmonary Hypertension | Drug: Tadalafil Drug: Placebo for tadalafil | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Tadalafil
Tadalafil 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.
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Drug: Tadalafil
Other Name: Adcirca
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Placebo Comparator: Placebo
Placebo 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.
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Drug: Placebo for tadalafil |
- 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 ]
- Cardiovascular Mortality [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]
- Heart Failure Hospitalization [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]
- All-cause Mortality [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]
- Composite Outcome of All-cause Mortality or CV Hospitalization (Myocardial Infarction, Acute Coronary Syndrome, Stroke, Arrhythmia, or Heart Failure) [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]
- Frequency of CV Hospitalizations [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]
- Frequency of HF Hospitalizations [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject ]
- Change in 6 Minute Walk Distance From Baseline to 3 Months [ Time Frame: Randomization to 3 months ]
- Change in MLHFQ Score From Baseline to 3 Months [ Time Frame: Randomization to 3 months ]
- Change in 6 Minute Walk Distance From Baseline to 18 Months [ Time Frame: Randomization to 18 months ]
- Trend in 6 Minute Walk Distance From Baseline Through 18 Months [ Time Frame: Randomization to 18 months ]
- Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline to 18 Months [ Time Frame: Randomization to 18 months ]
- Trend in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline Through 18 Months [ Time Frame: Randomization to 18 months ]

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910389

Principal Investigator: | Marc J. Semigran, MD | Massachusetts General Hospital | |
Principal Investigator: | Susan F Assmann, PhD | New England Research Institutes, Inc. | |
Principal Investigator: | Flora S Siami, MPH | New England Research Institutes, Inc. |
Responsible Party: | New England Research Institutes |
ClinicalTrials.gov Identifier: | NCT01910389 History of Changes |
Other Study ID Numbers: |
U01HL105463 ( U.S. NIH Grant/Contract ) |
First Posted: | July 29, 2013 Key Record Dates |
Results First Posted: | May 4, 2015 |
Last Update Posted: | May 4, 2015 |
Last Verified: | January 2014 |
Keywords provided by New England Research Institutes:
Heart failure Pulmonary hypertension tadalafil Phosphodiesterase Type 5 Inhibition |
Additional relevant MeSH terms:
Hypertension Heart Failure Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Heart Diseases Lung Diseases Respiratory Tract Diseases |
Tadalafil Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |