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Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass

ConditionPulmonary Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

FEV1/FVC ≤ 5th percentile; and

FEV1 z-score < -2.5

Prior to enrollment, evidence of severe restrictive defect with

TLC < 5th percentile

Trial population

The study population will include Pulmonary Hypertension patients from the University of Pennsylvania and Rhode Island Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • blood draw

    Diagnostic test

    Research blood draw

  • Short Performance Physical Battery

    Diagnostic test

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

  • Grip strength test

    Diagnostic test

    Measures grip strength

  • Six minute walk test

    Diagnostic test

    Measures distance walked in 6 minutes

  • Chest CT scan

    Radiation

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

  • Dual-Energy X-ray Absorptiometry Scan

    Radiation

    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

    Behavioral

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

  • 24 hour diet recall

    Behavioral

    A research dietitian will contact you and ask you to provide details of what you ate over the previous 24 hours

  • Echocardiogram

    Diagnostic test

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

  • Quality of Life Questionnaire (emPHasis 10)

    Behavioral

    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)

    Behavioral

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

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: PAH cohort at Penn and Brown11 interventions

Trial outcomes

Primary outcomes

1

Intake of food and nutrients

Adequacy of micronutrient and protein intake are derived from the two 24 hour diets recalls.

Time frame
One time at Baseline
2

Chest Computed Tomographic (CT) scan

The primary variables of interest will be total thoracic muscle volume measured on non-contrast chest CT scans

Time frame
One time at Baseline
3

Epicardial adipose tissue (EAT) volume

Derived from chest CT

Time frame
One time at Baseline
4

Metabolomics

Circulating proteins will be measured in plasma samples using the Olink Proteomics (Waltham, MA). In this assay, Olink uses a proprietary proximity extension assay technology to combine a detection step involving oligonucleotide-labeled antibodies with a proximity-dependent DNA polymerization step and a real-time quantitative PCR amplification step to measure relative levels of multiple biomarkers simultaneously. Two different panels will be used: Olink Explore 384 Cardiometabolic and Olink Explore 384 Inflammation.

Time frame
One time at Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Rhode Island Hospital

Collaborator

Source ClinicalTrials.gov
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