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Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

NCT01910389 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-05-04

Study results available
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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

Interventions

DRUG

Tadalafil

DRUG

Placebo for tadalafil

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Massachusetts General Hospital

    collaborator OTHER

  • Carelon Research

    lead OTHER

Principal Investigators

  • Marc J. Semigran, MD · Massachusetts General Hospital

  • Susan F Assmann, PhD · New England Research Institutes, Inc.

  • Flora S Siami, MPH · New England Research Institutes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910389 on ClinicalTrials.gov