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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    80
  • sponsor
    University of Washington
Updated on 10 February 2022
hypertension
vasodilator
right heart catheterization
pulmonary vasodilators

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.

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.

Details
Condition Pulmonary Arterial Hypertension, Right Heart Failure
Treatment Placebo, Famotidine 20 MG
Clinical Study IdentifierNCT03554291
SponsorUniversity of Washington
Last Modified on10 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note