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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Famotidine 20 mg capsule taken daily for 24 weeks.
Placebo capsule taken daily for 24 weeks.
University of Washington Medical Center
Seattle, Washington, United States
Change in Six-minute Walk Distance
To determine whether famotidine increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension
Time frame: 0 to 24 weeks
Chang in Log-transformed BNP
To determine whether famotidine reduces log-transformed BNP at 24 weeks
Time frame: 0 to 24 weeks
Proportion of Participants With New York Heart Association (NYHA) Functional Class of I or II at Week 24
NYHA functional class is graded from 1 to 4 (1: no symptoms of heart failure; 2: symptoms of heart failure with moderate exertion; 3: symptoms of heart failure with mild exertion; 4: symptoms of heart failure at rest). As such, NYHA functional class 1 is considered better than NYHA functional class 4.
Time frame: 24 weeks
Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE)
To determine whether famotidine improves right ventricular morphology at 24 weeks including improved right ventricular dilation and TAPSE
Time frame: 0 to 24 weeks
Change in Health Related Quality of Life (emPHasis-10 Questionnaire)
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).
Time frame: 0 to 24 weeks
Percent of Participants by Arm Who Added PAH Focused Care (Increased Diuretics, Escalating Doses of Pulmonary Vasodilators, and/or Adding Additional Pulmonary Vasodilators) Over 24 Weeks.
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To determine whether famotidine decreases the need to escalate PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding an additional pulmonary vasodilator). The confidence interval includes a negative percent (e.g. a participant who de-escalated care).
Time frame: 0 to 24 weeks