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Sponsors and Collaborators: |
MetroHealth Medical Center GCRC |
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Information provided by: | MetroHealth Medical Center |
ClinicalTrials.gov Identifier: | NCT00781508 |
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 |
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Heart Failure Left Ventricular Dysfunction |
Drug: sildenafil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Single Dose Sildenafil in Heart Failure Patients Improves 6-Minute Walk Test by a Reduction in Left Ventricular Filling Pressure |
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 |
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sildenafil: Experimental
Effect of sildenafil on left ventricular filling pressures in patients with heart failure
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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
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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.
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert C Bahler, MD | 216 778-8215 | r.bahler@metrohealth.org |
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 |
Principal Investigator: | Robert C Bahler, MD | MetroHealth Medical Center |
Responsible Party: | MetroHealth Medical Center ( Robert C Bahler, MD ) |
Study ID Numbers: | MO1RR000080 |
Study First Received: | October 28, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00781508 |
Health Authority: | United States: Institutional Review Board |
heart failure, left sided ventricular dysfunction diastolic dysfunction sildenafil |
Ventricular Dysfunction Heart Failure Heart Diseases Ventricular Dysfunction, Left Sildenafil |
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