Effects of Viagra on Heart Function in Patients With Heart Failure
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 25 - 75 |
| Updated: | 5/5/2014 |
| Start Date: | December 2006 |
| End Date: | October 2009 |
| Contact: | Robert C Bahler, MD |
| Email: | r.bahler@metrohealth.org |
| Phone: | 216 778-8215 |
Single Dose Sildenafil in Heart Failure Patients Improves 6-Minute Walk Test by a Reduction in Left Ventricular Filling Pressure
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.
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.
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.
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.
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
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