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NCT00781508 · ClinicalTrials.gov registry record · Phase 4
Effects of Viagra on Heart Function in Patients With Heart Failure
A Phase 4 study, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT00781508 is a Phase 4 study that has completed, run by MetroHealth Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT00781508, a Phase 4 study, has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00781508
The ClinicalTrials.gov registry entry for NCT00781508 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00781508 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00781508 about?
NCT00781508 is a clinical study titled "Effects of Viagra on Heart Function in Patients With Heart Failure". 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 systemi...
What is the current status of trial NCT00781508?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2006-12. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00781508?
The interventions under investigation include: Placebo (OTHER), sildenafil (DRUG).
Who is sponsoring clinical trial NCT00781508?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
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