Sildenafil in Heart Failure With Reactive Pulmonary Hypertension (Sildenafil-HF)

Maya Guglin

Status and phase: Terminated; Phase 4

Conditions: Heart Failure With Reactive Pulmonary Hypertension

Treatments: Drug: Placebo; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02304705

14-0628-F3R

Details and patient eligibility

About

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.

Full description

Patients will be screened at the time of a diagnositic Right Heart Catheterization. Patients will be selected based on pressures measured during this procedure, current medications, and current symptoms. At baseline a 6 minute walk test and quality of life questionnaire will be administered. Medical records will be reviewed and results of recent testing will be recorded. Qualifying participants will be randomized to receive 90 days of either placebo or sildenafil 20 mg three times a day. Randomized patients will be followed for safety and efficacy by phone and as otherwise clinically indicated.

At the end of the 90 day treatment period, patients will be evaluated via 6 minute walk, quality of life questionnaire, and other diagnostic tests as clinically indicated. Primary outcome will be change in the 6 minute walk distance. Secondary outcomes will be based on clinically available results such as change in heart pressures measured by right heart catheterization and echocardiogram.

At the end of the treatment period, providers and patients will be unblinded in order to optimize further treatment.

To achieve statistical significance, 64 patients will be enrolled and randomized.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo three times per day, orally

Treatment:

Drug: Placebo

Sildenafil

Active Comparator group

Description:

Sildenafil 20 mg three times per day, orally

Treatment:

Drug: Sildenafil