Sildenafil in Heart Failure With Reactive Pulmonary Hypertension

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sildenafil in US Heart Failure Patients (SilHF-US)

NCT03460470

Heart Failure Pulmonary Hypertension

UNKNOWN PHASE3

Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH

NCT01726049

Heart Failure, Diastolic Pulmonary Hypertension

COMPLETED PHASE3

Effects of Oral Sildenafil on Mortality in Adults With PAH

NCT02060487

Pulmonary Arterial Hypertension

TERMINATED PHASE4

Study of Sildenafil in Advanced Heart Failure.

NCT00309790

Congestive Heart Failure

COMPLETED PHASE3

To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

NCT00430716

Pulmonary Arterial Hypertension

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure With Reactive Pulmonary Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo three times per day, orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One capsule three times daily by mouth for 90 days

Sildenafil

Sildenafil 20 mg three times per day, orally

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

20 mg three times daily by mouth for 90 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sildenafil

20 mg three times daily by mouth for 90 days

Intervention Type DRUG

Placebo

One capsule three times daily by mouth for 90 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Viagra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No