Study of Sildenafil in Advanced Heart Failure.

Conditions

Congestive Heart Failure

Keywords

exercise stress test

Brief summary

Despite advances in medical therapy for patients with heart failure, one-third of patients remain limited by fatigue and shortness of breath. Our previous study concluded that one dose of sildenafil (Viagra) lead to an improvement in heart pressure and exercise capacity. Currently sildenafil is not FDA approved for the treatment of heart failure. The purpose of this study is to determine if treatment with sildenafil for 12 weeks in patients with heart failure can improve exercise capacity and quality of life in people with heart failure.

Detailed description

This study will compare two groups of patients. One group will receive sildenafil and the other group will receive a placebo (a pill which looks like sildenafil, but contains no medication). Patients will undergo a heart catheterization, echocardiogram and exercise stress test. Patients will then take study medication for 12 weeks. A repeat heart catheterization, echocardiogram and exercise stress test will then be performed.

Rajeev Malhotra, Bishnu P. Dhakal, Aaron S. Eisman, Paul P. Pappagianopoulos, Ashley Dress et al. (9 authors)

Circulation Heart Failure2016-06-0195 citations

10.1161/circheartfailure.115.003011

Exercise oscillatory ventilation in systolic heart failure: an indicator of impaired hemodynamic response to exercise.

Murphy RM, Shah RV, Malhotra R, Pappagianopoulos PP, Hough SS, Systrom DM, Semigran MJ, Lewis GD.

2011-08-2983 citations

10.1161/circulationaha.111.024141

Pulmonary vascular response patterns during exercise in left ventricular systolic dysfunction predict exercise capacity and outcomes.

Lewis GD, Murphy RM, Shah RV, Pappagianopoulos PP, Malhotra R, Bloch KD, Systrom DM, Semigran MJ.

2011-02-03131 citations

10.1161/circheartfailure.110.959437

Interventions

DRUGsildenafil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Age \>18 years Ejection fraction \<40% Heart failure limited by fatigue and shortness of breath Pulmonary artery hypertension

Exclusion criteria

Patients taking the following medications: nitroglycerine pill/patch/paste, isordil, Imdur, antifungal agents and certain antidepressants. Patients with a history of optic neuropathy or unexplained visual impairment. Patients with anemia. \-

Design outcomes

Primary

Measure	Time frame
Patients will have the following performed at baseline and again after taking study medication for 12 weeks: exercise capacity measured by exercise stress test, heart pressure measured by a heart catheterization and	—
quality of life measured by questionnaires at baseline and at 12 weeks	—

Outcome results

None listed