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Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass

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
Mentioned in the study description

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

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • 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 study looks at muscle loss in people with pulmonary arterial hypertension (PAH), or high blood pressure in the lung arteries. It studies how fat around the heart may play a role and how muscle loss affects daily activity, quality of life, and hospital stays.

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

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

Eligibility

Who can join

  • Sign a form agreeing to join before any study procedures.
  • Have an eligible type of PAH: with no known cause, passed down in families, or caused by drugs or toxins.
  • PAH linked to connective tissue disease, HIV, a heart problem present at birth, or high blood pressure in the liver’s blood vessels also qualifies.
  • Have been diagnosed with PAH within the past 6 months, or have PAH and have been on stable treatment for at least 3 months.
  • Have PAH confirmed before joining by a right heart catheter test, which measures pressure inside the heart and lung blood vessels. Results must meet the study’s pressure and blood flow limits.

Who can't join

  • Have breathing tests showing a moderately severe problem getting air out of the lungs, based on the study’s limits.
  • Have breathing tests showing a severe limit in how much air the lungs can hold, based on the study’s limits.
  • Have been hospitalized within the week before joining because the right side of the heart was failing to pump well enough.
  • Have disease of the aortic or mitral heart valve that is more than moderate.
  • Have a test within the year before screening showing that the heart’s main pumping chamber pushes 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: * 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 sites (2)

PA

RI