Assessing heart function in children with pulmonary hypertension
Non-Invasive Evaluation of Right Ventricular - Pulmonary Arterial Coupling in Children With Elevated Pulmonary Vascular Resistance
University of California, San Francisco · NCT05484596
This study is trying to find a better way to understand heart function in children with pulmonary hypertension by using non-invasive methods to see how their hearts are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT05484596 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children aged 1-21 years who are referred for cardiac catheterization due to concerns about pulmonary hypertension. It aims to develop a non-invasive scoring system to identify ventriculo-arterial uncoupling, a condition that can lead to decreased cardiac output and right ventricular failure. The study will measure pulmonary vascular resistance and right ventricular function using advanced techniques, including cardiac catheterization. The goal is to improve the understanding of heart function in pediatric patients with elevated pulmonary vascular resistance.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-21 years with structurally normal hearts who are being evaluated for pulmonary hypertension.
Not a fit: Patients with pulmonary hypertension secondary to pulmonary venous hypertension or those unable to undergo necessary tests like MRI or CPET may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better non-invasive methods for assessing heart function in children with pulmonary hypertension.
How similar studies have performed: While the approach of developing non-invasive scoring systems is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children 1-21 years of age * Patients referred for cardiac catheterization for hemodynamic evaluation due to concern for pulmonary hypertension * Structurally normal heart Exclusion Criteria: * Pulmonary hypertension secondary to pulmonary venous hypertension defined as pulmonary capillary wedge pressure of more than or equal to 15mmHg * Pulmonary hypertension secondary to mixed pulmonary arterial and venous hypertension * Patient will be excluded from performing an MRI if they have: claustrophobia, metal implants or allergy to contrast * Patients will be excluded from performing a cardiopulmonary exercise test (CPET) if they are: 1) less than 8 years or 2) unable to follow instructions to run on a treadmill.
Where this trial is running
San Francisco, California and 1 other locations
- Pediatric Pulmonary Hypertension Program — San Francisco, California, United States (RECRUITING)
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Gurumurthy Hiremath, MD — University of Minnesota
- Study coordinator: Brittany Faanes, MPH, CCRP
- Email: grego318@umn.edu
- Phone: 612-625-5929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Vascular Resistance Abnormality, pulmonary vascular resistance, pediatric, VA uncoupling