Comparing aerobic and leg training for patients with pulmonary arterial hypertension

Peripheral Limitations in Pulmonary Hypertension and Effects of Muscle Training - The PH Training Trial

This study is testing whether whole body aerobic training or leg training with weights helps people with pulmonary arterial hypertension feel better and improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT05968859 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of whole body aerobic training versus isolated leg training with weights on symptoms and quality of life in patients diagnosed with Pulmonary Arterial Hypertension (PAH). Participants will undergo different training regimens to determine which approach yields better outcomes in managing their condition. The study will include both PAH patients and healthy controls to provide a comprehensive comparison of the interventions. The research will be conducted at the Mayo Clinic in Rochester, Minnesota.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Pulmonary Arterial Hypertension who are symptomatic and meet specific health criteria.

Not a fit: Patients with recent hospitalizations due to heart failure or those who have recently started pulmonary vasodilator treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the management and quality of life for patients suffering from pulmonary arterial hypertension.

How similar studies have performed: Other studies have shown promising results with exercise interventions in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Pulmonary Arterial Hypertension (PAH) Subjects:

   1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
   2. NYHA Class II-IV
   3. LVEF ≥ 40 % within the preceding year.
   4. No hospitalizations due to heart failure in the preceding 30 days.
   5. No recent initiation of pulmonary vasodilator in the last 60 days
   6. Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR\>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP \<25 mm Hg).
   7. Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms
2. Healthy Controls:

   1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
   2. No known diagnosis of heart failure

Exclusion Criteria:

* Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
* Planned coronary, carotid, or peripheral artery revascularization.
* Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease).
* Wheelchair bound or orthopedic inability to exercise
* Chronic hypoxemia with inability to exercise without oxygen supplementation (PAH Subjects) or need for oxygen supplementation (Healthy Controls)
* Skeletal muscle myopathy
* History of rhabdomyolysis
* Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening.
* Receipt of any investigational medicinal product within 30 days before screening
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
* Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
* Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Yogesh Reddy, M.B.B.S — Mayo Clinic
• Study coordinator: Circulatory Failure Research Team

Conditions: Pulmonary Arterial Hypertension, Healthy, Muscle Training