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Trial record 19 of 31 for:    nhlbi | Recruiting, Not yet recruiting Studies | Heart Failure | United States

Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension (REHAB-PH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554291
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : November 14, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Peter Leary, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Right Heart Failure Drug: Famotidine 20 MG Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Famotidine

20mg of oral famotidine (pill) daily

Other names: Pepcid

Drug: Famotidine 20 MG
Famotidine 20 mg capsule taken daily for 24 weeks.

Placebo Comparator: Placebo
Daily oral placebo (pill)
Other: Placebo
Placebo capsule taken daily for 24 weeks.




Primary Outcome Measures :
  1. Six-minute walk distance [ Time Frame: 0 to 24 weeks ]

Secondary Outcome Measures :
  1. nt-pro-BNP [ Time Frame: 0 to 24 weeks ]
  2. New York Heart Association (NYHA) functional class [ Time Frame: 0 to 24 weeks ]
    NYHA functional class will be determined by a 10 question decision aid.

  3. Health related quality of life (emPHasis-10 questionnaire) [ Time Frame: 0 to 24 weeks ]
    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.

  4. Frequency of escalation for PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding additional pulmonary vasodilators) [ Time Frame: 0 to 24 weeks ]
  5. Right ventricular function by echocardiogram [ Time Frame: 0 to 24 weeks ]
    TAPSE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554291


Contacts
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Contact: Laurie Hogl 206-543-8334 lalnaser@uw.edu

Locations
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United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Laurie Hogl    206-543-8334    lalnaser@uw.edu   
Principal Investigator: Peter J Leary, MD, PhD         
Sub-Investigator: Yonatan Buber, MD         
Sub-Investigator: Sam G Rayner, MD         
Sub-Investigator: Lia M Barros, DNP         
Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Peter J Leary, MD, PhD University of Washington
Publications of Results:
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Responsible Party: Peter Leary, Director, Pulmonary Vascular Disease Program, University of Washington
ClinicalTrials.gov Identifier: NCT03554291    
Other Study ID Numbers: STUDY00005002
1R61HL142539-01 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Peter Leary, University of Washington:
famotidine
H2 blocker
H2 antagonist
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs