A Study of Pulmonary Hypertension Peripheral Limitations

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05968859
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yogesh Reddy, M.B.B.S
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension, Healthy

Arms & Interventions

Arms

Active Comparator: Aerobic Training

Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo aerobic training for 12 weeks, and then repeat study assessments.

Experimental: Leg Training

Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo leg training for 12 weeks, and then repeat study assessments.

No Intervention: Healthy Controls

Healthy controls will be enrolled to complete the baseline study assessments for generation of normal reference values for comparison. Healthy controls will not undergo randomized exercise training interventions or repeat assessments.

Interventions

Behavioral: - Aerobic Training

Aerobic training will be conducted at 30 minutes 3 times a week using brisk walking with target heart rates goals based on percentage of peak HR reserve (HRR= peak-rest HR) during baseline exercise right heart catheterization (RHC). The target HR will progress over the study period from 50% to 70% of peak HR reserve added to resting HR using the standard Karvonen formula (Goal HR = rest HR + target % of HRR). HR will be monitored using Fitbits to guide training intensity with raw data analyzed using the Fitabase platform to monitor compliance

Behavioral: - Leg Training

Leg training will be performed using assigned ankle weights to perform knee extension while seated. Initial weight assignment will be guided by a protocol driven in-person exercise tolerance test using varying weights to identify the optimal initial and target training weight for each patient based on the 10 repetition maximum weight identified during this test. Leg training weight will begin at 40% of the baseline 10-repetition maximum weight for weeks 1-4 during which time patients will be required to complete 3 sets of 10 repetitions (30 repetitions total) on 3 days per week. For weeks 4-8, 55% of the initial 10-repetition maximum weight will be used for 4 sets of 10 repetitions (40 repetitions total). For weeks 8-12, 70% of the initial 10-repetition maximum weight will be used for 5 sets of 10 repetitions (50 repetitions total).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Circulatory Failure Research Team

507-255-2200

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