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Active Not RecruitingNCT07132788

Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTblood drawResearch blood draw
DIAGNOSTIC_TESTShort Performance Physical Batterytest of physical performance, which involves measuring movement from sitting to standing, walking speed, and balance
DIAGNOSTIC_TESTGrip strength testMeasures grip strength
DIAGNOSTIC_TESTSix minute walk testMeasures distance walked in 6 minutes
RADIATIONChest CT scanX-ray and computer technology takes detailed pictures of the organs and structures inside your chest
RADIATIONDual-Energy X-ray Absorptiometry ScanUses X-ray technology to measure the mineral density of your bones, and provides a ratio of fat tissue to lean mass (muscle) and bone
BEHAVIORALActivity monitoringA device worn on your non-dominant wrist which measures motion/ movement/ activity
BEHAVIORAL24 hour diet recallA research dietitian will contact you and ask you to provide details of what you ate over the previous 24 hours
DIAGNOSTIC_TESTEchocardiogramUltrasound technology to create moving images of your heart, valves, and chambers
BEHAVIORALQuality of Life Questionnaire (emPHasis 10)The emPHasis-10 is a pulmonary hypertension-specific questionnaire which is scored from 0-50 (with higher scores indicating worse quality of life.)
BEHAVIORALInternational Physical Activity Questionnaire Short Form (IPAQ-SF)The IPAQ-SF is a small set of questions to obtain comparable estimates of physical activity.

Timeline

Start date
2025-05-01
Primary completion
2029-09-30
Completion
2029-09-30
First posted
2025-08-20
Last updated
2025-08-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07132788. Inclusion in this directory is not an endorsement.