Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients (CFR-OHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03231371
Recruitment Status : Completed
First Posted : July 27, 2017
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Information provided by (Responsible Party):
Bryan Goldstein, University of Michigan

Brief Summary:
Heart transplantation is a life-sustaining therapy that allows patients with either congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time, however, the transplanted heart can develop problems. One of the more common and troubling problems is the development of stenoses, or narrowings, within the coronary arteries. These narrowings, technically referred to as coronary artery vasculopathy (CAV for short), account for the single most common cause of death or need for repeat heart transplant in persons more than one year post-transplant. Traditionally, CAV has been diagnosed at cardiac catheterization using coronary angiography (where dye is directly injected into the coronary blood vessels and viewed using special x-ray equipment called fluoroscopy). There is no good treatment for CAV aside from treatment of symptoms and listing for repeat heart transplantation. The goal of this study is to test several newer methods of diagnosing CAV. The first is called coronary flow reserve (catheterization test). The second is called Endo-PAT (a finger probe test) and the third is called contrast-enhanced cardiac MRI (MRI test, only for patients 12 and older). The older method (coronary angiography) will still be used in all cases, in addition to the new tests The goal is, one day, to be able to diagnose patients with CAV earlier in the course, prior to a patient's development of abnormal angiograms. If this can be done, it is possible that better therapies will be able to be used to stop or even reverse the development of CAV, perhaps reducing, or at least delaying, the need for repeat heart transplantation.

Condition or disease Intervention/treatment Phase
Orthotopic Heart Transplant Drug: Adenosine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Detection of Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients: A Prospective Assessment Using Coronary Flow Reserve and Contrast-Enhanced Cardiac MRI
Study Start Date : November 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
Experimental: Study Arm Drug: Adenosine
Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).

Primary Outcome Measures :
  1. Coronary Flow Reserve (CFR) [ Time Frame: Baseline testing (acute only), 3 minutes of adenosine infusion ]
    Ratio of peak to baseline coronary flow velocity (CFV)

Secondary Outcome Measures :
  1. Gadolinium Enhancement by Cardiac MRI [ Time Frame: Baseline MRI only ]
    Categorical measure - yes or no; number of participants with gadolinium enhancement

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients age 1 - 25 years who are status-post OHT (≤18 years at the time of transplantation) and undergoing routine post-transplant surveillance catheterization for endomyocardial biopsy and coronary angiography

Exclusion Criteria:

  • The presence of sick sinus syndrome or 2nd or 3rd degree atrioventricular block (without a functioning implanted pacemaker)
  • Hemodynamically significant valvular disease
  • Severe asthma or bronchospasm, known severe CAV
  • Pulmonary hypertension.
  • Patients taking digoxin
  • Verapamil and dipyridamole are also excluded given known interactions with adenosine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03231371

United States, Michigan
University of MIchigan-Congenital Heart Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Bryan Goldstein
Principal Investigator: Bryan Goldstein, MD University of Michigan

Responsible Party: Bryan Goldstein, Principal Investigator, Clinical Lecturer, University of Michigan Identifier: NCT03231371     History of Changes
Other Study ID Numbers: HUM23585
First Posted: July 27, 2017    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bryan Goldstein, University of Michigan:
Orthotopic Heart Transplant

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action