Study Summary
This trial will test whether the drug famotidine is safe and effective in treating pulmonary arterial hypertension.
Eligible Conditions
- Pulmonary Arterial Hypertension
- Right-sided Heart Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 0 to 24 weeks
0 to 24 weeks
Frequency of escalation for PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding additional pulmonary vasodilators)
Health related quality of life (emPHasis-10 questionnaire)
New York Heart Association (NYHA) functional class
Right ventricular function by echocardiogram
Six-minute walk distance
nt-pro-BNP
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Famotidine
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
80 Total Participants · 2 Treatment Groups
Primary Treatment: Famotidine 20 MG · Has Placebo Group · Phase 2
Famotidine
Drug
Experimental Group · 1 Intervention: Famotidine 20 MG · Intervention Types: DrugPlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Famotidine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0 to 24 weeks
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,597 Previous Clinical Trials
1,569,069 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,593 Previous Clinical Trials
46,945,766 Total Patients Enrolled
20 Trials studying Pulmonary Arterial Hypertension
2,204 Patients Enrolled for Pulmonary Arterial Hypertension
Peter J Leary, MD, PhDPrincipal InvestigatorUniversity of Washington
Eligibility Criteria
Age 18 - 80 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:in a patient with a diagnosis of Eisenmenger syndrome
Within five years, a right heart catheterization demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg, occlusion pressure of ≤ 15 mmHg, and pulmonary vascular resistance of ≥ 3 wood units can diagnose Eisenmenger syndrome in a patient.
People who have had a right heart catheterization in the last five years and have a mean pulmonary arterial pressure of at least 25 mmHg and an occlusion pressure of 15-20 mmHg will be considered for this study if their pulmonary vascular resistance is at least 9 wood units and they are being treated with a medication specific to pulmonary hypertension.
The text states that the person can walk a distance of 50 meters on their own.
, any race
This is an announcement for anyone who is male or female and is between the ages of 18 and 80
WHO Group 1 Pulmonary Arterial Hypertension is a rare, life-threatening disorder in which the pressure in the pulmonary arteries is abnormally high
did not appear to alter the primary endpoint in the Phase 3 INOVA trial
The study found that there was no significant difference in the primary endpoint between the group who received a stable dose of pulmonary vasodilators for 30 days prior to randomization and the group who did not.
Who else is applying?
What state do they live in?
| Washington | 100.0% |
What site did they apply to?
| University of Washington Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How many prior treatments have patients received?
| 3+ | 100.0% |
References
- Leary, Peter J., Richard A. Kronmal, David A. Bluemke, Peter M. Buttrick, Kenneth L. Jones, David P. Kao, Steven M. Kawut, et al.. 2018. “Histamine H2 Receptor Polymorphisms, Myocardial Transcripts, and Heart Failure (from the Multi-ethnic Study of Atherosclerosis and Beta-blocker Effect on Remodeling and Gene Expression Trial)”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/j.amjcard.2017.10.016.
- Leary, Peter J., R. Graham Barr, David A. Bluemke, Michael R. Bristow, Richard A. Kronmal, Joao A. Lima, David D. Ralph, Corey E. Ventetuolo, and Steven M. Kawut. 2014. “H2 Receptor Antagonists and Right Ventricular Morphology: The MESA Right Ventricle Study”. Annals of the American Thoracic Society. American Thoracic Society. doi:10.1513/annalsats.201407-344oc.
- Leary, Peter J., Ryan J. Tedford, David A. Bluemke, Michael R. Bristow, Susan R. Heckbert, Steven M. Kawut, Eric V. Krieger, et al.. 2016. “Histamine H 2 Receptor Antagonists, Left Ventricular Morphology, and Heart Failure Risk”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2016.01.045.
- Leary, Peter J., Edward Hess, Anna E. Barón, Kelley R. Branch, Gaurav Choudhary, Catherine L. Hough, Bradley A. Maron, et al.. 2018. “H2 Receptor Antagonist Use and Mortality in Pulmonary Hypertension: Insight from the VA-CART Program”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201801-0048le.
- Leary, Peter J., Ryan J. Tedford, David A. Bluemke, Michael R. Bristow, Susan R. Heckbert, Steven M. Kawut, Eric V. Krieger, et al.. 2016. “Histamine H 2 Receptor Antagonists, Left Ventricular Morphology, and Heart Failure Risk”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2016.01.045.
- 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 Study of Atherosclerosis and Beta-Blocker Effect on Remodeling and Gene Expression Trial). Am J Cardiol. 2018 Jan 15;121(2):256-261. doi: 10.1016/j.amjcard.2017.10.016. Epub 2017 Oct 20.
- 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 Care Med. 2018 Jun 15;197(12):1638-1641. doi: 10.1164/rccm.201801-0048LE. No abstract available.
- Peter Leary 2019. "Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03554291.
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