Repurposing a Histamine Antagonist to Benefit Patients With 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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-07-11

Brief Summary

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

This is a Phase 2, single-center, randomized placebo controlled trial of famotidine (an H2 receptor antagonist) in adults with pulmonary arterial hypertension. The study will evaluate the safety and clinical efficacy of a 24-week course of famotidine.

Related Clinical Trials

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

Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

NCT03015402

Pulmonary Hypertension Secondary Heart Failure

COMPLETED PHASE2

Targeting the Right Ventricle in Pulmonary Hypertension

NCT01839110

Pulmonary Hypertension

COMPLETED PHASE4

Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial Hypertension

NCT00323024

Pulmonary Hypertension

WITHDRAWN PHASE2

Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension

NCT02080533

Pulmonary Arterial Hypertension

COMPLETED PHASE1/PHASE2

A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2

NCT05737940

Pulmonary Hypertension (World Health Organization Group 2) Heart Failure

COMPLETED PHASE2

Detailed Description

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

Pulmonary arterial hypertension (PAH) is one of many conditions that put stress and strain on the right side of the heart. This stress and strain can cause right heart failure. Although there are medications to treat PAH, there are currently no medications that act directly on the heart to improve right heart function. This is different than left heart failure where one of the cornerstones of treatment is medication targeted at the heart to improve left heart function.

Famotidine is a well-tolerated, over-the-counter, and inexpensive medication. Preliminary results suggest that famotidine may help the right heart to adapt and strengthen when stressed instead of fail; however, these results are suggestive and not definitive. A randomized controlled trial is required to evaluate the possibility that famotidine can impact right heart function.

Participants in the study will take famotidine or placebo for 24 weeks. They will have three study visits at 0, 12, and 24 weeks. These visits will add 20-30 minutes to the standard clinic visits at those time points and there will be an echocardiogram at weeks 0 and 24. There will also be one phone visit at 4 weeks to check-in. Some participants may elect to participate in exercise testing and/or right heart catheterization at weeks 0 and 24; however, this is not required to participate in the trial.

Conditions

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

Pulmonary Arterial Hypertension Right Heart Failure

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

DOUBLE

Participants Investigators

Study Groups

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

Famotidine

20mg of oral famotidine (pill) daily

Other names: Pepcid

Group Type EXPERIMENTAL

Famotidine 20 MG

Intervention Type DRUG

Famotidine 20 mg capsule taken daily for 24 weeks.

Placebo

Daily oral placebo (pill)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsule taken daily for 24 weeks.

Interventions

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

Famotidine 20 MG

Famotidine 20 mg capsule taken daily for 24 weeks.

Intervention Type DRUG

Placebo

Placebo capsule taken daily for 24 weeks.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Male or female, age 18 to 80
* WHO Group 1 Pulmonary Arterial Hypertension
* NYHA Functional Class II, III, or IV at screening
* Stable dose of pulmonary vasodilators for 30 days prior to randomization
* Right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg, occlusion pressure of ≤ 15 mmHg, and pulmonary vascular resistance of ≥ 3 wood units
* Participants with a right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg and occlusion pressure of 15 - 20 mmHg will be considered for inclusion if the pulmonary vascular resistance ≥ 9 wood units and they are being treated with pulmonary arterial hypertension specific therapy
* Able to walk with/without a walking aid for a distance of at least 50 meters

Exclusion Criteria

* Pregnant or lactating
* Non-group 1 pulmonary hypertension or veno-occlusive disease
* History of interstitial lung disease, unless subject has collagen vascular disease and has pulmonary function testing conducted within 12 months demonstrating a total lung capacity of ≥ 60 %
* Has received or will receive an investigational drug, device, or study within 30 days or during the course of study
* Left sided myocardial disease as evidenced by left ventricular ejection fraction \< 40%
* Any other clinically significant illness or abnormal laboratory values (measured during the Screening period) that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data
* Anticipated survival less than 1 year due to concomitant disease
* Regularly taking an H2 receptor antagonist within 30 days of enrollment
* Creatinine clearance \< 30 mL/min
* History of bariatric surgery
* Current treatment for HIV

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No