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Heart Failure | Effects of Viagra on Heart Function in Patients With Heart Failure

Heart Failure research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Adults with Class III congestive heart failure and impaired left ventricular systolic function. - A prior BNP level ≥ 200 pg/mL. - Previously documented systolic pulmonary artery pressure >40 mmHg. - Clinically stable for a minimum of 6 weeks. - Able to give informed consent, Exclusion Criteria: - Unable to give informed consent. - Currently taking nitrates. - A HF exacerbation within the past 6 weeks. - Co-morbid conditions that could limit their walking. - Have a resting systolic blood pressure < 110 mmHg

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Heart Failure

Left Ventricular Dysfunction

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Other:PlaceboChanges in left ventricular filling pressure 1 hour after oral administration of placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

sildenafilEffect of oral administration of a single dose of sildenafil 50 mg on left ventricular filling pressures as evaluated 1 hr after sildenafil administration in patients with heart failure

placeboInactive placebo prepared to mimic the appearance of sildenafil.

Study Status

Completed

Start Date: December 2006

Completed Date: November 2009

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil

Secondary Outcome: The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg.

Study sponsors, principal investigator, and references

Principal Investigator: Robert C Bahler, MD

Lead Sponsor: MetroHealth Medical Center

Collaborator: National Center for Research Resources (NCRR)

More information:https://clinicaltrials.gov/show/NCT00781508

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