Clinical trial NCT02304705: Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
Official title: Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure With Reactive Pulmonary Hypertension
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Exercise Tolerance
timeFrame: Baseline and 90 days
Secondary outcomes:
Other outcomes:
measure: Change in Right Ventricular Function
timeFrame: Baseline and 90 day
measure: Change in Cardiac Output Relative to Body Surface Area (Cardiac Index)
timeFrame: Baseline and 90 days
measure: Change in Pulmonary Vascular Resistance
timeFrame: Baseline and 90 days
measure: Change in Blood Pressure
timeFrame: Baseline and 90 days
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Maya E Guglin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guglin M, Rajagopalan N, Anaya P, Charnigo R. Sildenafil in heart failure with reactive pulmonary hypertension (Sildenafil HF) clinical trial (rationale and design). Pulm Circ. 2016 Jun;6(2):161-7. doi: 10.1086/685548.