Pulmonary Arterial Hypertension Clinical Trial
— REHAB-PHOfficial title:
Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
Verified date | July 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | July 11, 2023 |
Est. primary completion date | July 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Leary PJ, Barr RG, Bluemke DA, Bristow MR, Kronmal RA, Lima JA, Ralph DD, Ventetuolo CE, Kawut SM. H2 receptor antagonists and right ventricular morphology: the MESA right ventricle study. Ann Am Thorac Soc. 2014 Nov;11(9):1379-86. doi: 10.1513/AnnalsATS. — View Citation
Leary PJ, Hess E, Baron AE, Branch KR, Choudhary G, Hough CL, Maron BA, Ralph DD, Ryan JJ, Tedford RJ, Weiss NS, Zamanian RT, Lahm T. H2 Receptor Antagonist Use and Mortality in Pulmonary Hypertension: Insight from the VA-CART Program. Am J Respir Crit Ca — View Citation
Leary PJ, Kronmal RA, Bluemke DA, Buttrick PM, Jones KL, Kao DP, Kawut SM, Krieger EV, Lima JA, Minobe W, Ralph DD, Tedford RJ, Weiss NS, Bristow MR. Histamine H2 Receptor Polymorphisms, Myocardial Transcripts, and Heart Failure (from the Multi-Ethnic Stu — View Citation
Leary PJ, Tedford RJ, Bluemke DA, Bristow MR, Heckbert SR, Kawut SM, Krieger EV, Lima JA, Masri CS, Ralph DD, Shea S, Weiss NS, Kronmal RA. Histamine H2 Receptor Antagonists, Left Ventricular Morphology, and Heart Failure Risk: The MESA Study. J Am Coll C — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Invasive hemodynamics (sub-study): Stroke Volume Index | To determine whether famotidine increases stroke volume index at 24 weeks | 0 to 24 weeks | |
Other | Cardiopulmonary Exercise Testing (sub-study): Maximal oxygen uptake | To determine whether famotidine increases maximal oxygen uptake in individuals with pulmonary arterial hypertension at 24 weeks | 0 to 24 weeks | |
Other | Invasive hemodynamics (sub-study): Hemodynamics | Exploratory: To explore whether famotidine improves hemodynamics (wedge, RA, PVR) at 24 weeks | 0 to 24 weeks | |
Other | Cardiopulmonary Exercise Testing (sub-study): Exercise | Exploratory: To explore whether famotidine improves exercise (Ve/VCO2 ratio, total achieved wattage). | 0 to 24 weeks | |
Primary | Six-minute walk distance | To determine whether famotidine increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension | 0 to 24 weeks | |
Secondary | BNP | To determine whether famotidine reduces BNP at 24 weeks | 0 to 24 weeks | |
Secondary | New York Heart Association (NYHA) functional class | To determine whether famotidine improves New York Heart Association (NYHA) functional class at 24 weeks | 0 to 24 weeks | |
Secondary | 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 | 0 to 24 weeks | |
Secondary | 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). | 0 to 24 weeks | |
Secondary | Frequency of escalation for PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding additional pulmonary vasodilators) | 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) | 0 to 24 weeks |
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