Clinical trial for Pulmonary Arterial Hypertension
Official title Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Substudy
ClinicalTrials.gov ID: NCT07781709
What this study is testing
- What it's testing
- After completion of the Baseline study visit for the main study (MUSCLE UP-PH), people at the University of Pennsylvania location will be invited to participate in an optional substudy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- mPAP \> 20 mmHg; and
- PAWP or LVEDP ≤ 15 mmHg
- PVR \> 2 Wood units
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.