RECRUITING

A Study of Pulmonary Hypertension Peripheral Limitations

Conditions

Pulmonary Arterial Hypertension Healthy Muscle Training

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-01-02

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05968859

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Circulatory Failure Research Team

CONTACT

(507) 255-2200

Yogesh Reddy

CONTACT

(507) 284-3687

Reddy.Yogesh@mayo.edu

Principal Investigator

Yogesh Reddy, M.B.B.S

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Yogesh Reddy, M.B.B.S, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-02

Study Completion Date2028-07

Study Record Updates

Study Start Date2024-01-02

Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

Muscle Training

Additional Relevant MeSH Terms

Pulmonary Arterial Hypertension
Healthy