CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
sildenafil +1 moredrug
Likely dose
sildenafil 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00781508
NCT00781508Phase 4Completed

Single Dose Sildenafil in Heart Failure Patients Improves 6-minute Walk Test by a Reduction in Left Ventricular Filling Pressure

MetroHealth Medical Center·interventional·Posted Oct 29, 2008·Updated Jul 2, 2014

In Brief

A Phase 4 clinical trial evaluating sildenafil and Placebo for Heart Failure and Left Ventricular Dysfunction. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Sildenafil (Viagra) is known to reduce pulmonary hypertension. Heart failure patients also have pulmonary hypertension and several recent reports have shown that sildenafil leads to an improvement in their exercise capacity. In these studies sildenafil caused a reduction in the pulmonary and systemic vascular resistances, improved pulmonary gas diffusion and perhaps increased cardiac output. It is uncertain if left ventricular filling pressures are reduced and whether there is improvement in left ventricular relaxation. The investigators hypothesize that in heart failure patients the improvement in exercise capacity associated with sildenafil is related to a significant reduction in left ventricular filling pressures. The investigators propose to study 20 patients with stable but moderately symptomatic heart failure. The study design is a randomized cross-over trial of the administration of a single dose of sildenafil 50 mg or a matching placebo. Exercise capacity will be determined before and after the oral administration of sildenafil 50 mg or placebo. Left ventricular filling pressures will be assessed by Doppler echocardiography and the serum level of B-type natriuretic peptide (BNP is known to increase with higher left ventricular filling pressures). After an initial echocardiogram and performing a 6 minute walk test, the patient will then be given either sildenafil or a matching placebo in a randomized double-blind fashion. One hr later a blood sample for serum BNP, the echocardiogram and the 6 minute walk test will be repeated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 29, 2008
Enrollment StartDec 1, 2006
Primary CompletionSep 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.7 years ago

Interventions

sildenafildrug

Changes in left ventricular filling pressure 1 hour after the administration of a single oral dose of sildenafil 50 mg.

Placeboother

Changes in left ventricular filling pressure 1 hour after oral administration of placebo