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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
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
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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