Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Carelon Research
With
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
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
Clareo Health | Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure
