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

Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Penn Pilot Low Load Resistance Exercise Training Substudy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The subject will have their vital signs checked, will complete the E10 questionnaire, have blood drawn, and will complete exercise testing: an occlusion device (Kaatsu B2 model) will be applied to the thigh area and a wireless NIRS device (PortaMon, Artinis, The Netherlands) will be applied over their right gastrocnemius muscle and secured with strap."
  • "A post-exercise blood draw will completed during the recovery phase."
  • "At the 12-week visit, the participant will also complete the E10 questionnaire and that will conclude their substudy participation."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This optional study tests how light strength exercises, mainly for the calf muscles, affect blood flow and how muscles take oxygen from the blood. It is for adults with pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs, who have finished the first MUSCLE UP-PH study visit at the University of Pennsylvania.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Take part in the main MUSCLE UP study.
  • Sign a consent form before any required study procedures.
  • Be age 18 or older.
  • Have an eligible type of PAH: with no known cause, inherited, caused by drugs or toxins, or linked to certain other conditions.
  • Eligible linked conditions are connective tissue disease, HIV, heart disease present at birth, or high blood pressure in the liver’s portal vein.
  • Have been diagnosed with PAH within 6 months of joining, or have PAH and be on stable treatment for 3 months before joining.
  • Have PAH confirmed by a right heart catheter test, which measures pressure and blood flow. Required results are mPAP above 20 mmHg, PAWP or LVEDP at most 15 mmHg, and PVR above 2 Wood units.

Who can't join

  • Breathing tests show moderately severe trouble moving air out of the lungs: FEV1/FVC at or below the 5th percentile and an FEV1 z-score below -2.5.
  • Breathing tests show severely limited lung expansion: total lung capacity below the 5th percentile and an FEV1 z-score below -4.
  • Have more than moderate disease of the aortic or mitral heart valve.
  • A test within 1 year of screening shows the heart’s main pumping chamber pumps out less than 40% of its blood with each beat.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Participating the main MUSCLE UP Study: * 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 * 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 * More than moderate aortic or mitral valve disease * LVEF \< 40% within 1 year of screening * Pregnancy

Study sites (1)

PA