Phase 2
N=80
Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
Pulmonary Arterial Hypertension · Right Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03554291 ↗Enrolled (actual)
80
Serious AEs
16.5%
Results posted
Aug 2024
Primary outcome: Primary: Change in Six-minute Walk Distance — -17.0; 4.7 meters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Famotidine 20 MG (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Six-minute Walk Distance |
-17.0; 4.7 | — |
| SECONDARY Chang in Log-transformed BNP |
-0.05; 0.08 | — |
| SECONDARY Proportion of Participants With New York Heart Association (NYHA) Functional Class of I or II at Week 24 |
0.71; 0.53 | — |
| SECONDARY Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE) |
-1.5; 0.9; 0.1; 0.7 | — |
| SECONDARY Change in Health Related Quality of Life (emPHasis-10 Questionnaire) |
-1.7; -1.3 | — |
| SECONDARY 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. |
8.1; 5.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03554291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.