NCT07132788Recruiting
Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 1 Jul 2025
- Start date
- 29 Jul 2024
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- University of Pennsylvania
- NCT number
- NCT07132788
What you commit to
- Study type: Observational
- Planned participants: 150
- From 29 Jul 2024 to the primary completion date, 1 Jul 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior to enrollment, evidence of moderately severe obstructive ventilator defect with:
- FEV1/FVC ≤ 5th percentile; and
- FEV1 z-score \< -2.5
- Prior to enrollment, evidence of severe restrictive defect with
- TLC \< 5th percentile
- FEV1 z-score \< -4
- Prior to enrollment, hospitalization (within 1 week) for decompensated right heart failure
Other illness
- More than moderate aortic or mitral valve disease
Lab values
- LVEF \< 40% within 1 year of screening
Other
- Pregnancy
Who the study is looking for
- Signed informed consent prior to initiation of any study mandated procedure.
- Diagnosis of PAH belonging to one of the following subgroups of Group 1 PH according to the updated clinical classification \[Humbert 2022\]
- Idiopathic (IPAH)
- Heritable (HPAH)
- Drugs or toxins induced
- Associated (APAH) with one of the following:
- Connective tissue disease;
- Human immunodeficiency virus (HIV) infection;
- Congenital heart disease; or
- Portopulmonary hypertension
- Diagnosis of PAH within 6 months of enrollment or diagnosis of PAH and on stable therapy for 3 months prior to enrollment
- Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC), prior to enrollment showing:
- mPAP \> 20 mmHg; and
- PAWP or LVEDP ≤ 15 mmHg
- PVR \> 2 Wood units
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.