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NCT02462941 · ClinicalTrials.gov registry record · Phase 1
Analysis of Adenosine on Sinus and Atrioventricular Nodal Conduction in the Pediatric Transplanted Heart
A Phase 1 study of Atrioventricular Block and Sinus Bradycardia, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT02462941 is a Phase 1 study of Atrioventricular Block and Sinus Bradycardia that has completed, run by Columbia University. The registered enrollment target is 80 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02462941, a Phase 1 study of Atrioventricular Block and Sinus Bradycardia, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
Heart transplants save the lives of nearly 500 children in heart failure per year. Columbia is one of the largest pediatric heart transplant centers in the world, averaging 25 transplants per year, and providing ongoing care to nearly 250 children with transplanted hearts. After transplant, children are at increased risk to develop sudden onset of abnormally fast heart rates. This research project will study adenosine, a medication that is routinely used to slow fast heart rates in non-transplanted children (i.e. normal hearts), and its effects on the transplanted heart. Adenosine is often not used in patients with transplanted hearts because, based on prior limited research in adult patients, the standard adult dose may have a longer medication effect, producing a slower heart rate for an undesirable period of time. However, the current alternatives to adenosine treatment are either inappropriate for the pediatric age range, or have increased risk of unwanted side effects. This research project will answer two questions: is adenosine safe to give a child who has had a heart transplant, and will it be effective in treating the fast heart rate? All pediatric heart transplant patients undergo regular heart testing, known as a cardiac catheterization, one or more times per year. Three days before testing, participants will be asked to stop a regular medication, dipyridamole, because it slows the breakdown of adenosine in the body, and may increase its effects. (Of note, all patients that are on dipyridamole are also on aspirin, which gives a second line of heart protection, and will not be stopped.) After regular cardiac catheterization, all patients will already have intravenous (IV) access to give medication. Also, this setting allows the opportunity to have a back-up pacing catheter in the heart, ensuring that there will not be a longer than desired effect from the medication. Adenosine will be given per a low-dose protocol until either the medication effect is see
Conditions Studied
Interventions
- DRUG Adenosine
- PROCEDURE Cardiac catheterization
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02462941
The ClinicalTrials.gov registry entry for NCT02462941 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Atrioventricular Block appearing as the primary indexed condition, and to 2 interventions - of which Adenosine is the first listed.
NCT02462941 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02462941 about?
NCT02462941 is a clinical study titled "Analysis of Adenosine on Sinus and Atrioventricular Nodal Conduction in the Pediatric Transplanted Heart". Heart transplants save the lives of nearly 500 children in heart failure per year. Columbia is one of the largest pediatric heart transplant centers in the world, averaging 25 transplants per year, and providing ongoing care to nearly 250 children with transplanted hearts. After transplant, children...
What is the current status of trial NCT02462941?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2015-07. Estimated completion is 2017-07.
What conditions does trial NCT02462941 study?
This clinical trial studies the following conditions: Atrioventricular Block, Sinus Bradycardia.
What interventions are being tested in trial NCT02462941?
The interventions under investigation include: Adenosine (DRUG), Cardiac catheterization (PROCEDURE).
Who is sponsoring clinical trial NCT02462941?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02462941 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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