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NCT03822442 · ClinicalTrials.gov registry record
MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
A clinical trial of Heart Failure and Congenital Heart Defects, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT03822442: Recruiting study of Heart Failure and Congenital Heart Defects, sponsored by Children's National Research Institute.
NCT03822442 is a study of Heart Failure and Congenital Heart Defects that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 200 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03822442, a study of Heart Failure and Congenital Heart Defects, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. We were the first to perform MR-guided cardiac catheterization in US children, and have accumulated the largest US experience, having performed over 75 procedures to date. Our unique experience puts us in strong position to leverage this technology to improve care of children with cardiomyopathy and transplant. Using an integrated approach, we will simultaneously (1) validate imaging measures of cardiac edema and fibrosis by correlating T1 and T2 map images with endomyocardial biopsy (EMB) results in Aim 1; (2) overlay T1, T2 map images into our x-ray system to display "hotspots" of T1 and T2 abnormalities to guide EMB in Aim 2; and (3) obtain radiation-free hemodynamic data in a highly vulnerable pediatric population by using CMR to guide catheter manipulation in the ICMR suite in Aim 3. Age and diagnosis-matched historical controls will be identified from the last 10 years at Children's National as a control population for specific purposes of comparing (1) EMB yield without image overlay and (2) Radiation exposure during X-ray guided right heart catheterization. Identical information will be obtained and stored in the same 45CFR compliant database. Historical controls will be identified from the cardiac catheterization database by searching for age and diagnosis. A waiver of consent will be applicable here, as it would be inconvenient, insensitive and not feasible to consent families who have already undergone treatment.
Primary Outcome
Correlate MRI imaging sequences that can detect inflammation and fibrosis to quantities of inflammation and fibrosis seen on biopsy specimens taken from the same region.
Conditions Studied
Study Locations (1)
District of Columbia
- Children's National Health System - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-12-10 |
| Est. Completion | 2026-12-31 |
What NCT03822442 shows while recruiting
NCT03822442 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 0 interventions.
NCT03822442 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03822442 about?
NCT03822442 is a clinical study titled "MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients". Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. We were the first t...
What is the current status of trial NCT03822442?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2019-12-10. Estimated completion is 2026-12-31.
What conditions does trial NCT03822442 study?
This clinical trial studies the following conditions: Heart Failure, Congenital Heart Defects, Cardiac Imaging Techniques.
Who is sponsoring clinical trial NCT03822442?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03822442 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03822442's enrollment target sits among peer trials
200 165th of 397 higher than 229 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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