NCT01910389

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Heart Failure
• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Tadalafil
DRUG	Placebo for tadalafil

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-07-29
• Last updated: 2015-05-04
• Results posted: 2015-05-04

Locations

63 sites across 2 countries: United States, Canada