NCT03554291

Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Pulmonary Arterial Hypertension
• Right Heart Failure

Interventions

Type	Name	Description
DRUG	Famotidine 20 MG	Famotidine 20 mg capsule taken daily for 24 weeks.
OTHER	Placebo	Placebo capsule taken daily for 24 weeks.

Timeline

• Start date: 2019-05-01
• Primary completion: 2023-07-11
• Completion: 2023-07-11
• First posted: 2018-06-13
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study