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Understanding Muscle Loss in Pulmonary Arterial Hypertension

This study aims to understand why people with pulmonary arterial hypertension (PAH) lose muscle and how this affects their daily lives and hospital stays. Researchers will look at how fat around the heart might play a role in muscle loss. You may be able to join if you are 18 or older and have a diagnosis of Group 1 PAH, including idiopathic (unknown cause), heritable (runs in families), drug- or toxin-induced, or associated with conditions like connective tissue disease. The study involves diagnostic tests like blood draws, physical performance tests (like walking and balance), grip strength tests, and a chest CT scan (a special X-ray). The goal is to find ways to improve the quality of life and physical function for people with PAH. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 150 participants. It is not specified if it is randomized, open-label, or blinded.
What's involved
You would attend a baseline visit for vital signs, a research blood draw, and various physical tests. Some participants will also have a second visit at Week 12, which includes a physical therapist session with muscle oxygenation measurements.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at one time at baseline. A subset of patients will have a second study visit at Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07132788

Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass

Recruiting
Not specifiedAges 18+Observational
University of Pennsylvania
~150 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:blood drawShort Performance Physical BatteryGrip strength testSix minute walk testChest CT scanDual-Energy X-ray Absorptiometry Scan

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intake of food and nutrients
Measured over One time at Baseline
+9 more outcomes measured

Conditions

Pulmonary Hypertension

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Pulmonary Arterial Hypertension

NCT07132788

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Rhode Island Hospital

    Providence, Rhode Islandstudy coordinator listed

    Recruiting

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nadine Al-Naamani, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Rebecca Gallagher Research Project Manager, MSEd
[email protected]
215-294-9755
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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
More than moderate aortic or mitral valve disease
LVEF \< 40% within 1 year of screening
Pregnancy

What this trial measures

  • Intake of food and nutrientsOne time at Baseline

    Adequacy of micronutrient and protein intake are derived from the two 24 hour diets recalls.

  • Chest Computed Tomographic (CT) scanOne time at Baseline

    The primary variables of interest will be total thoracic muscle volume measured on non-contrast chest CT scans

  • Epicardial adipose tissue (EAT) volumeOne time at Baseline

    Derived from chest CT

  • MetabolomicsOne time at Baseline

    Circulating proteins will be measured in plasma samples using the Olink Proteomics (Waltham, MA). In this assay, Olink uses a proprietary proximity extension assay technology to combine a detection step involving oligonucleotide-labeled antibodies with a proximity-dependent DNA polymerization step and a real-time quantitative PCR amplification step to measure relative levels of multiple biomarkers simultaneously. Two different panels will be used: Olink Explore 384 Cardiometabolic and Olink Explore 384 Inflammation.

  • Right ventricular (RV) functionOne time at Baseline

    Determined from 2D echocardiography

  • AdiponectinOne time at Baseline

    Measured using a solid phase sandwich ELISA (R\&D Systems, Inc., Minneapolis, MN) with a minimum detectable dose of 0.246 ng/mL and intra-assay variations (CV) 2.5%-4.7%.

  • Low lean massOne time at Baseline

    Using the data from the dual-energy X-ray absorptiometry, we will generate fat mass index-adjusted appendicular lean mass index (ALMIFMI) Z-Scores derived from age, sex, and race/ethnicity specific models.16 Low lean mass will be defined as ALMIFMI ZScore less than or equal to -1.

  • Accelerometry measuresOne time at Baseline

    Step counts and activity intensity (sedentary time, time spent doing light, moderate, and vigorous activity) will be derived.

  • Health-Related Quality of Life (HRQOL)One time at Baseline

    The emPHasis-10 is a questionnaire used to assess the impact of pulmonary hypertension (PH) on a person's life. It consists of 10 items, each scored on a scale of 0 to 5, resulting in a total score ranging from 0 to 50. Higher scores indicate a greater symptom burden and poorer quality of life.

  • Measurement of oxyhemoglobin and deoxyhemoglobin concentration pre and post- exercise at baseline and Week 12. Measurement of time to recovery of oxyhemglobin post-exercise at baseline and at Week 12.12 weeks

    We will measure oxy-hemoglobin and deoxyhemoglobin concentration using NIRS applied to the biceps and calf pre- and post- exercise at baseline and Week 12. Moreover, we will measure time to recovery of oxy-hemglobin post-exercise at baseline and at Week 12.