Clinical trial NCT05968859: A Study of Pulmonary Hypertension Peripheral Limitations
Official title: Peripheral Limitations in Pulmonary Hypertension and Effects of Muscle Training - The PH Training Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Healthy
Keywords: Muscle Training
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-08-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are doing this research study to compare whole body aerobic training with isolated leg training (with weights) and its impact on effectiveness in symptoms and quality of life in patients with Pulmonary Arterial Hypertension (PAH).


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.

Primary outcomes:
measure: Change in skeletal muscle O2 diffusive conductance (Dm) during supine cycle exercise
timeFrame: Baseline, approximately 12 weeks
Secondary outcomes:
measure: Change in peak O2 consumption (peak VO2) during supine cycle exercise
timeFrame: Baseline, approximately 12 weeks
measure: Change in skeletal muscle O2 diffusive conductance (Dm) during single knee-extensor exercise
timeFrame: Baseline, approximately 12 weeks
measure: Change in maximal mitochondrial respiration
timeFrame: Baseline, approximately 12 weeks
measure: Change in Quality of Life as measured by the 36-Item Short-Form Survey (SF-36)
timeFrame: Baseline, approximately 8 weeks, approximately 12 weeks
measure: Change in Quality of Life as measured by the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) questionnaire
timeFrame: Baseline, approximately 8 weeks, approximately 12 weeks
measure: Change in Quality of Life as measured by the emPHasis-10 questionnaire
timeFrame: Baseline, approximately 8 weeks, approximately 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yogesh Reddy, M.B.B.S
role: PRINCIPAL_INVESTIGATOR
References: