Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03554291
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Washington
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Peter J Leary, MD, PhD
Principal Investigator Affiliation University of Washington
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension, Right Heart Failure
Additional Details

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.

Arms & Interventions

Arms

Experimental: Famotidine

20mg of oral famotidine (pill) daily Other names: Pepcid

Placebo Comparator: Placebo

Daily oral placebo (pill)

Interventions

Drug: - Famotidine 20 MG

Famotidine 20 mg capsule taken daily for 24 weeks.

Other: - Placebo

Placebo capsule taken daily for 24 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Washington Medical Center, Seattle, Washington

Status

Address

University of Washington Medical Center

Seattle, Washington, 98195

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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