Overview

Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Status:
Terminated
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a double-blind, placebo controlled trial.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maya Guglin
University of Kentucky
Treatments:
Sildenafil Citrate
Criteria
Inclusion Criteria:

- Known chronic heart failure appropriately treated with Angiotensin converting enzyme
(ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated

- indication for right heart catheterization

- pulmonary artery mean pressure >25 mmHg

- pulmonary capillary wedge pressure > 15 mmHg

- pulmonary vascular resistance > 3 Wood units

Exclusion Criteria:

- hypersensitivity, allergy, or intolerable side effect to sildenafil

- history of primary pulmonary hypertension, connective tissue disorder, severe chronic
obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt

- co-morbidities, limited exercise intolerance:

- morbid obesity (BMI >40)

- COPD with oxygen dependence

- severe peripheral vascular disease with intermittent claudication

- status post amputation of lower extremity at any level

- severe degenerative joint disease preventing normal walking