A Study of Pulmonary Hypertension Peripheral Limitations

Launched by MAYO CLINIC · Jul 20, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how two different types of exercise—whole body aerobic training and isolated leg training with weights—affect the symptoms and quality of life for patients with Pulmonary Arterial Hypertension (PAH). The goal is to see which type of training is more effective in helping these patients feel better and improve their daily activities.

To participate in this study, you need to be between the ages of 65 and 74 and have a diagnosis of PAH, which means your heart has trouble pumping blood to your lungs. You should not have been hospitalized for heart failure recently or started new treatments for PAH in the last couple of months. Healthy individuals without heart problems can also join the study as a comparison group. If you decide to take part, you will be asked to provide your consent and will undergo some exercises to assess your symptoms. This trial aims to help understand better ways to manage PAH through exercise.

Gender

ALL

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.