Trials / Active Not Recruiting
Active Not RecruitingNCT07132788
Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | blood draw | Research blood draw |
| DIAGNOSTIC_TEST | Short Performance Physical Battery | test of physical performance, which involves measuring movement from sitting to standing, walking speed, and balance |
| DIAGNOSTIC_TEST | Grip strength test | Measures grip strength |
| DIAGNOSTIC_TEST | Six minute walk test | Measures distance walked in 6 minutes |
| RADIATION | Chest CT scan | X-ray and computer technology takes detailed pictures of the organs and structures inside your chest |
| RADIATION | Dual-Energy X-ray Absorptiometry Scan | Uses X-ray technology to measure the mineral density of your bones, and provides a ratio of fat tissue to lean mass (muscle) and bone |
| BEHAVIORAL | Activity monitoring | A device worn on your non-dominant wrist which measures motion/ movement/ activity |
| BEHAVIORAL | 24 hour diet recall | A research dietitian will contact you and ask you to provide details of what you ate over the previous 24 hours |
| DIAGNOSTIC_TEST | Echocardiogram | Ultrasound technology to create moving images of your heart, valves, and chambers |
| BEHAVIORAL | Quality of Life Questionnaire (emPHasis 10) | The emPHasis-10 is a pulmonary hypertension-specific questionnaire which is scored from 0-50 (with higher scores indicating worse quality of life.) |
| BEHAVIORAL | International Physical Activity Questionnaire Short Form (IPAQ-SF) | The IPAQ-SF is a small set of questions to obtain comparable estimates of physical activity. |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2029-09-30
- Completion
- 2029-09-30
- First posted
- 2025-08-20
- Last updated
- 2025-08-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07132788. Inclusion in this directory is not an endorsement.