Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass

Study acronym: MUSCLE UP-PH
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary endpoint removed 10 → 9 primary endpoints
Primary endpoint added 9 → 10 primary endpoints
Primary endpoint removed 10 → 9 primary endpoints
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Record History

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  1. Primary endpoint(s) modified
    • Start date moved earlier from May 1, 2025 to Jul 29, 2024
    • Eligibility criteria expanded, about 25 words
  2. Primary endpoint(s) modified
    • Interventions modified
    • Eligibility criteria revised
    • Secondary endpoints shortened, about 5 words
    v5
  3. Primary endpoint(s) modifiedv4 Show 4 more changesShow less
    • Phase changed: not applicable → not specified
    • Study sites: 1 to 2
    • Study description shortened, about 141 words
    • Collaborators: 1 to 2
  4. Primary and study completion moved earlier from Sep 30, 2029 to Jul 1, 2029v3
  5. Phase: Not specified to Not applicablev2 Show 6 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Primary endpoints: 8 to 10
    • Interventions: 24 hour diet recall (Behavioral), Activity monitoring (Behavioral), Chest CT scan (Radiation), Dual-Energy X-ray Absorptiometry Scan… to 24 hour diet recall (Behavioral), Activity monitoring (Behavioral), Chest CT scan (Radiation), Dual-Energy X-ray Absorptiometry Scan…
    • Study description expanded, about 141 words
    • Site details revised
    • Study arms: 0 to 1
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients with pulmonary arterial hypertension (PAH) are at increased risk of muscle loss and decreased physical activity. This study will aim to (1) understand the way in which muscle loss occurs in PAH, particularly the role of fat surrounding the heart, and (2) look at the impact muscle loss has on quality of life, daily physical activity, and hospitalizations in patients with PAH. The findings from this study could help identify potentially treatable factors that may improve the overall quality of life and physical functioning of patients with PAH. Subjects will be asked to attend a baseline visit where the following will be performed: * Measure your vital signs * Undergo a research blood draw, less than 4 tablespoons * Provide a urine pregnancy test (if applicable) * Review demographics, personal history, and medical history * Review current PAH medications * Complete questionnaires on how your PAH affects you * Complete a test of physical performance * Complete a grip strength test * Undergo an echocardiogram (Echo) * Complete a six-minute walk test * Undergo a Chest CT Scan * Undergo a scan of your body composition (DXA scan) * Obtain a weight and body composition measurement on the InBody Scale Subjects will also complete activity moniotring, two 24-hour diet recalls, and participate in remote follow-up visits every 6 months
Trial Details
NCT Number NCT07132788
Lead Sponsor University of Pennsylvania
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Rhode Island Hospital
Conditions
(from sponsor)		 Pulmonary Hypertension
Related terms Hypertension, Pulmonary
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov