Effects of Viagra on Heart Function in Patients With Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Bahler, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00781508
First received: October 28, 2008
Last updated: June 23, 2014
Last verified: June 2014
  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 Phase
Heart Failure
Left Ventricular Dysfunction
Drug: sildenafil
Other: Placebo
Phase 4

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:
  • Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil [ Time Frame: Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg. [ Time Frame: Measured 1 hr after oral administration of sildenafil 50 mg ] [ Designated as safety issue: No ]
    A standardized course was used to determine the distance walked (meters) during a 6 min walk supervised by a nurse trained in performance of the test.


Enrollment: 10
Study Start Date: December 2006
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sildenafil
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
Changes in left ventricular filling pressure 1 hour after the administration of a single oral dose of sildenafil 50 mg.
Other Name: Viagra
Other: Placebo
Changes in left ventricular filling pressure 1 hour after oral administration of placebo
Placebo Comparator: placebo
Inactive placebo prepared to mimic the appearance of sildenafil.
Drug: sildenafil
Changes in left ventricular filling pressure 1 hour after the administration of a single oral dose of sildenafil 50 mg.
Other Name: Viagra
Other: Placebo
Changes in left ventricular filling pressure 1 hour after oral administration of placebo

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 10 patients with stable, symptomatic HF Class III. The study design is a randomized cross-over assignment of the administration of a single oral 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 60 minutes 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 a single dose of either sildenafil or a matching placebo in a randomized double-blind fashion. The randomization was performed so that half of the group would receive the placebo on the initial test and sildenafil on the subsequent test and the other half would have the reverse sequence. One hr after the medication/placebo administration a blood sample for serum BNP, the echocardiogram and the 6 minute walk test will be repeated. After completion of the above protocol, the patient will return in 48 hrs and the protocol will be repeated with the predetermined assignment of either placebo or sildenafil.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Robert C Bahler, MD MetroHealth Medical Center
  More Information

No publications provided

Responsible Party: Robert Bahler, Cardiologist Professor of Medicine CWRU, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00781508     History of Changes
Other Study ID Numbers: MO1RR000080, Grant Number UL1 RR024989, ULI RR024989
Study First Received: October 28, 2008
Results First Received: April 22, 2013
Last Updated: June 23, 2014
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
Ventricular Dysfunction, Left
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
Urological Agents

ClinicalTrials.gov processed this record on September 30, 2014