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Effects of Viagra on Heart Function in Patients With Heart Failure

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ClinicalTrials.gov Identifier: NCT00781508
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : June 23, 2014
Last Update Posted : July 2, 2014
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Robert Bahler, MetroHealth Medical Center

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.

Condition or disease Intervention/treatment Phase
Heart Failure Left Ventricular Dysfunction Drug: sildenafil Other: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : December 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781508


Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Robert C Bahler, MD MetroHealth Medical Center

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 ( Other Grant/Funding Number: CWRU-CTSC )
ULI RR024989 ( Other Grant/Funding Number: NIH/NCRR CWRU-CTSC )
First Posted: October 29, 2008    Key Record Dates
Results First Posted: June 23, 2014
Last Update Posted: July 2, 2014
Last Verified: June 2014

Keywords provided by Robert Bahler, 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 Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents