Recruiting

Pulmonary Arterial Hypertension

Sponsor:

University of Pennsylvania

Code:

NCT07132788

Conditions

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

blood draw

Short Performance Physical Battery

Grip strength test

Six minute walk test

Chest CT scan

Study Details

Brief 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

Pulmonary Hypertension

Study ID

NCT07132788

Start date

May 1, 2025

Status verified date

Aug, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

PAH cohort at Penn and Brown

Participants will be asked to:

Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall

Interventions

blood draw

Research blood draw

Short Performance Physical Battery

test of physical performance, which involves measuring movement from sitting to standing, walking speed, and balance

Grip strength test

Measures grip strength

Six minute walk test

Measures distance walked in 6 minutes

Chest CT scan

X-ray and computer technology takes detailed pictures of the organs and structures inside your chest

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

Activity monitoring

A device worn on your non-dominant wrist which measures motion/ movement/ activity

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

Echocardiogram

Ultrasound technology to create moving images of your heart, valves, and chambers

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.)

International Physical Activity Questionnaire Short Form (IPAQ-SF)

The IPAQ-SF is a small set of questions to obtain comparable estimates of physical activity.

Primary outcome measure

  • Intake of food and nutrients [ Time Frame: One time at Baseline ]
  • Chest Computed Tomographic (CT) scan [ Time Frame: One time at Baseline ]
  • Epicardial adipose tissue (EAT) volume [ Time Frame: One time at Baseline ]
  • Metabolomics [ Time Frame: One time at Baseline ]
  • Right ventricular (RV) function [ Time Frame: One time at Baseline ]
  • Adiponectin [ Time Frame: One time at Baseline ]
  • Low lean mass [ Time Frame: One time at Baseline ]
  • Accelerometry measures [ Time Frame: One time at Baseline ]
  • Health-Related Quality of Life (HRQOL) [ Time Frame: One time at Baseline ]
  • 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. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Rebecca Gallagher Research Project Manager, MSEd

215-294-9755Rebecca.lang@Pennmedicine.upenn.edu

Nicole Denney, MS

215-615-4156nicole.denney@pennmedicine.upenn.edu

Locations

University of Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Nicole Denney, MS

Nicole.denney@Pennmedicine.upenn.edu

Principal Investigator:

Nadine Al-Naamani, MD

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Allyson Sherman-Roe Senior Clincial Research Program Coordinator

401-444-2733ashermanroe1@brownhealth.org

Ashley Dennett Senior Clinical Research Assistant

401-606-4745adennett@brownhealth.org

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • pulmonary hypertension
  • body composition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-09-01.