Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure
Status: | Recruiting |
---|---|
Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 3/1/2014 |
Start Date: | November 2013 |
End Date: | April 2017 |
Contact: | Julie E Miller, MPH |
Email: | pitch-hf@neriscience.com |
Phone: | 617-972-3197 |
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.
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.
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
We found this trial at
62
sites
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Johns Hopkins Hosp From the 1889 opening of The Johns Hopkins Hospital, to the opening...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
University of Utah Research is a major component in the life of the U benefiting...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
![University of Michigan Health System](/wp-content/uploads/logos/university-of-michigan-health-system.jpg)
University of Michigan Health System The University of Michigan is home to one of the...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
Philadelphia, Pennsylvania 19129
(215) 991-8100
![Drexel University College of Medicine](/wp-content/uploads/logos/drexel-university-college-of-medicine.jpg)
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Temple University Temple University is many things to many people. A place to pursue life's...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)