Effects of Viagra on Heart Function in Patients With Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by MetroHealth Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00781508
First received: October 28, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Failure
Left Ventricular Dysfunction
Drug: sildenafil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Single Dose Sildenafil in Heart Failure Patients Improves 6-Minute Walk Test by a Reduction in Left Ventricular Filling Pressure

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • The primary outcome measure is a fall in the left ventricular filling pressure in association with administration of sildenafil [ Time Frame: The left ventricular filling presure will be assessed at 60 minutes after the administration of sildenafil ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary outcome is the distance walked with the 6-minute walk test after the administration of sildenafil [ Time Frame: Determned at the end of the 6-minute walk test ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2006
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sildenafil
Effect of sildenafil on left ventricular filling pressures in patients with heart failure
Drug: sildenafil
Changes in left ventricular filling pressure after the administration of a single doe of sildenafil 50 mg by mouth
Drug: sildenafil
A single oral dose of sildenafil 50 mg

Detailed Description:

Sildenafil (Viagra) has been extensively studied in patients with idiopathic pulmonary hypertension. It reduces pulmonary vascular resistance, improves exercise capacity and is now an approved therapy for this condition. Heart failure (HF) patients also have pulmonary hypertension and several recent reports have shown that sildenafil leads to an improvement in their exercise capacity. In HF sildenafil causes a reduction in the pulmonary and systemic vascular resistances, improves pulmonary gas diffusion and perhaps increases cardiac output. It is uncertain if left ventricular filling pressures are reduced and whether there is improvement in left ventricular relaxation. We hypothesize that in HF patients the improvement in exercise capacity associated with sildenafil is related to a significant reduction in left ventricular filling pressures. We propose to study 20 patients with stable, symptomatic HF Class III. The study design is a randomized cross-over trial of the administration of a single dose of sildenafil 50 mg or a matching placebo. Patients will be excluded if walking is impaired due to non-cardiac conditions or if they are taking nitrates. Exercise capacity will be determined before and after the oral administration of sildenafil 50 mg or placebo. The difference in the standardized 6 minute walk test (distance patient is able to walk over a 6 minute interval) will be used to assess exercise capacity. Left ventricular filling pressures will be assessed by Doppler echocardiography and the serum level of B-type natriuretic peptide (BNP). Evaluation of left ventricular relaxation will be determined by Doppler echocardiography techniques. Each patient will have a blood sample for BNP, an initial echocardiogram and perform a 6 minute walk test. They 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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781508

Contacts
Contact: Robert C Bahler, MD 216 778-8215 r.bahler@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Robert C Bahler, MD    216-778-8215    rbahler@metrohealth.org   
Contact: Robert C Bahler, MD    216 778-8215    rbahler@metrohealth.org   
Principal Investigator: Robert C Bahler, MD         
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Robert C Bahler, MD MetroHealth Medical Center
  More Information

No publications provided

Responsible Party: Robert C Bahler, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00781508     History of Changes
Other Study ID Numbers: MO1RR000080
Study First Received: October 28, 2008
Last Updated: October 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
heart failure, left sided
ventricular dysfunction
diastolic dysfunction
sildenafil

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014