Understanding Muscle Loss in Pulmonary Hypertension
Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass
Recruiting
Observational Study
Pulmonary Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
150 (estimated)
Sponsor
University of Pennsylvania · Other
Who this trial is looking for
This trial is looking for people with pulmonary arterial hypertension (PAH) to learn how muscle loss affects them. Participants will have various tests and follow-up visits over 6 months to gather information about their condition and health.
Are You a Good Fit for This Trial?
You may be able to join if
I have signed consent to participate.
I have been diagnosed with pulmonary arterial hypertension.
My PAH diagnosis is within the last 6 months or I have been stable on treatment for 3 months.
I have had a right heart catheterization showing specific PAH measurements.
You may not be able to join if
I have a severe lung condition.
I was hospitalized in the last week for heart failure.
I have serious heart valve disease.
My heart's pumping ability is below 40% within the last year.
I am currently pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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
Trial Locations
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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 …
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
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