Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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25 July 2023 |
Main ID: |
NCT03554291 |
Date of registration:
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31/05/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
REHAB-PH |
Scientific title:
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Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension |
Date of first enrolment:
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May 1, 2019 |
Target sample size:
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80 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03554291 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Peter J Leary, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Right Heart Failure
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Famotidine 20 MG
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Other: Placebo
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Primary Outcome(s)
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Six-minute walk distance
[Time Frame: 0 to 24 weeks]
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Secondary Outcome(s)
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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]
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New York Heart Association (NYHA) functional class
[Time Frame: 0 to 24 weeks]
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BNP
[Time Frame: 0 to 24 weeks]
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Health related quality of life (emPHasis-10 questionnaire)
[Time Frame: 0 to 24 weeks]
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Right ventricular morphology by echocardiogram (RV dilation and TAPSE)
[Time Frame: 0 to 24 weeks]
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Secondary ID(s)
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STUDY00005002
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1R61HL142539-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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