Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients

NCT03231371 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HUM23585
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthotopic Heart Transplant

Keywords

Orthotopic Heart Transplant

Outcome Measures

Primary Outcomes (1)

• Coronary Flow Reserve (CFR)

  Ratio of peak to baseline coronary flow velocity (CFV)

  Baseline testing (acute only), 3 minutes of adenosine infusion

Secondary Outcomes (1)

• Gadolinium Enhancement by Cardiac MRI

  Baseline MRI only

Study Arms (1)

Study Arm

EXPERIMENTAL

Drug: Adenosine

Interventions

Adenosine DRUG

Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).

Study Arm

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bryan Goldstein: lead

Study Sites (1)

University of MIchigan-Congenital Heart Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Adenosine

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Bryan Goldstein
• Organization: University of Michigan

Bryan.Goldstein@cchmc.org

Study Officials

• Bryan Goldstein, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Lecturer

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: July 27, 2017
• Study Start: November 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 26, 2017
• Results First Posted: September 26, 2017

Record last verified: 2017-08

Locations

US (1)