Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Substudy

NCT07781709 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 856202 SubstudyR01HL173533
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

After completion of the Baseline study visit for the main study (MUSCLE UP-PH), participants at the University of Pennsylvania location will be invited to participate in an optional substudy. The substudy will implement a low-load resistance exercise training for the lower extremities, focusing primarily on the gastrocnemius muscles. The goal of this intervention is to understand how low-load resistance training will impact blood flow and oxygen tissue extraction on the lower legs.

Conditions

Pulmonary Arterial Hypertension

Keywords

PAH; Exercise

Outcome Measures

Primary Outcomes (1)

• Difference in circulating level of adiponectin (ng/mL) pre- and post-exercise at baseline and at Week 12

  The investigators will measure adiponectin levels 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%.

  12 Weeks

Secondary Outcomes (3)

• Measurement of deoxyhemoglobin concentration pre and post-exercise at baseline and Week 12.

  12 weeks

• Measurement of oxyhemoglobin recovery post exercise at Baseline and Week 12

  12 weeks

• Measurement of oxyhemoglobin concentration pre and post- exercise at baseline and Week 12.

  12 weeks

Study Arms (1)

Low resistance exercise intervention

OTHER

Participants will be asked to perform a series of exercises recommend by the National Institute on Aging Go4Life campaign, namely seated heel raise, plantar flexion, sit to stand, and box squats. They will wear the portamon device to measure muscle oxygenation and have blood drawn to measure adiponectin before performing the above exercises at home for 12 weeks, and then be measured with the portamon device and undergo another flood draw again after 12 weeks.

Device: 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.; Diagnostic Test: Blood draw

Interventions

Blood draw DIAGNOSTIC_TEST

: The investigators will measure adiponectin levels 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%.Time Frame: 12 Weeks

Low resistance exercise intervention

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. DEVICE

: The investigators 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, the investigators will measure time to recovery of oxy-hemglobin post-exercise at baseline and at Week 12. Time Frame: 12 weeks

Also known as: Portamon device

Low resistance exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to initiation of any study mandated procedure.
• Male and female patient's ≥ 18 years of age.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Motor Activity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nadine Al-Namaani, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Gallagher Research Project Manager, MSEd

CONTACT

215-662-4088; rebecca.lang@pennmedicine.upenn.edu

Nicole Denney, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

US (1)