Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Substudy
Sponsored by University of Pennsylvania
About this study
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.
After obtaining informed consent, patients will be scheduled for an in-person substudy baseline visit. 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. The participant will be seated in a chair and allowed to rest for up to 10 minutes, and then the participant will begin performing seated heel raises. Once comfortable with the maneuver, the occlusion device will be inflated to systolic blood pressure (SBP) + 50 mmHg for 5 minutes and the participant will be asked to resume the seated heel …
Where this study is enrolling
- I'm interested
University of Pennsylvania Hospital
Philadelphia, Pennsylvania
Who can participate
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
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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.