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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Pulmonary Arterial Hypertension (PAH) Subjects:

‣ 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.

⁃ NYHA Class II-IV

⁃ LVEF ≥ 40 % within the preceding year.

⁃ No hospitalizations due to heart failure in the preceding 30 days.

⁃ No recent initiation of pulmonary vasodilator in the last 60 days

⁃ 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).

⁃ Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms

• Healthy Controls:

‣ 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.

⁃ No known diagnosis of heart failure

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Circulatory Failure Research Team
(507) 255-2200
Backup
Yogesh Reddy
Reddy.Yogesh@mayo.edu
(507) 284-3687
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2028-03
Participants
Target number of participants: 45
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov