Status:
RECRUITING
Mobile Health Intervention to Improve Exercise in Pediatric PH
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
13-19 years
Phase:
NA
Brief Summary
Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline ...
Eligibility Criteria
Inclusion
- Adolescents between ages 13-19 years.
- Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect).
- WHO functional class I-III
- Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
- Forced vital capacity \>65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor.
Exclusion
- Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.
- Pregnancy
- Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
- Functional class IV heart failure
- Requirement of \> 2 diuretic adjustment in the prior three months.
- Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
- Involved in any other investigational intervention.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06549452
Start Date
December 1 2024
End Date
November 1 2030
Last Update
April 8 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232