Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension (REHAB-PH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03554291|
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : November 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension Right Heart Failure||Drug: Famotidine 20 MG Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
20mg of oral famotidine (pill) daily
Other names: Pepcid
Drug: Famotidine 20 MG
Famotidine 20 mg capsule taken daily for 24 weeks.
Placebo Comparator: Placebo
Daily oral placebo (pill)
Placebo capsule taken daily for 24 weeks.
- Six-minute walk distance [ Time Frame: 0 to 24 weeks ]
- nt-pro-BNP [ Time Frame: 0 to 24 weeks ]
- New York Heart Association (NYHA) functional class [ Time Frame: 0 to 24 weeks ]NYHA functional class will be determined by a 10 question decision aid.
- Health related quality of life (emPHasis-10 questionnaire) [ Time Frame: 0 to 24 weeks ]To determine whether famotidine improves health related quality of life as estimated by the emPHasis-10 score. Each item on the emPHasis-10 questionnaire is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. EmPHasis-10 scores range from 0 to 50 with higher scores indicating worse quality of life.
- Frequency of escalation for PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding additional pulmonary vasodilators) [ Time Frame: 0 to 24 weeks ]
- Right ventricular function by echocardiogram [ Time Frame: 0 to 24 weeks ]TAPSE
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554291
|Contact: Laurie Hoglemail@example.com|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Laurie Hogl 206-543-8334 firstname.lastname@example.org|
|Principal Investigator: Peter J Leary, MD, PhD|
|Sub-Investigator: Yonatan Buber, MD|
|Sub-Investigator: Sam G Rayner, MD|
|Sub-Investigator: Lia M Barros, DNP|
|Principal Investigator:||Peter J Leary, MD, PhD||University of Washington|