Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 August 2024
• Main ID: NCT03554291
• Date of registration: 31/05/2018
• Prospective Registration: Yes
• Primary sponsor: University of Washington
• Public title: Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension REHAB-PH
• Scientific title: Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
• Date of first enrolment: May 1, 2019
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03554291
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Peter J Leary, MD, PhD
• Affiliation: University of Washington

Key inclusion & exclusion 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


Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Right Heart Failure

Intervention(s)

Other: Placebo

Drug: Famotidine 20 MG

Primary Outcome(s)

Change in Six-minute Walk Distance [Time Frame: 0 to 24 weeks]

Secondary Outcome(s)

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. [Time Frame: 0 to 24 weeks]

Proportion of Participants With New York Heart Association (NYHA) Functional Class of I or II at Week 24 [Time Frame: 24 weeks]

Chang in Log-transformed BNP [Time Frame: 0 to 24 weeks]

Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE) [Time Frame: 0 to 24 weeks]

Change in Health Related Quality of Life (emPHasis-10 Questionnaire) [Time Frame: 0 to 24 weeks]

Secondary ID(s)

STUDY00005002

1R61HL142539-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

Results

• Results available: Yes
• Date Posted: 09/08/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03554291