Effects of Viagra on Heart Function in Patients With Heart Failure

NCT00781508 | Completed Phase 4 Results

• 3 other identifiers: MO1RR000080Grant Number UL1 RR024989ULI RR024989
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Left Ventricular Dysfunction

Keywords

heart failure, left sided; ventricular dysfunction; diastolic dysfunction; sildenafil

Outcome Measures

Primary Outcomes (1)

• Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil

  Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e

  Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil

Secondary Outcomes (1)

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

  Measured 1 hr after oral administration of sildenafil 50 mg

Study Arms (2)

sildenafil

EXPERIMENTAL

Effect 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

Drug: sildenafil; Other: Placebo

placebo

PLACEBO COMPARATOR

Inactive placebo prepared to mimic the appearance of sildenafil.

Drug: sildenafil; Other: Placebo

Interventions

sildenafil DRUG

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

Also known as: Viagra

placebo; sildenafil

Placebo OTHER

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

placebo; sildenafil

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction, Left; Ventricular Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study was limited by the small number of participants. Additionally, the inclusion criterion of a systolic pulmonary artery pressure of \> 40 mmHg was no longer present in the majority of patients at the time they presented for study.

Results Point of Contact

• Title: Robert C. Bahler, MD
• Organization: MetroHealth Medical Center

rbahler@metrohealth.org

216 778-2431

Study Officials

• Robert C Bahler, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist Professor of Medicine CWRU

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: December 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 2, 2014
• Results First Posted: June 23, 2014

Record last verified: 2014-06

Locations

US (1)