Home Electrocardiogram (ECG) Monitoring After Heart Transplantation

NCT ID: NCT01365806

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 345 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2016-01-31

Brief Summary

The long-term goal of this research is to apply novel technology for detection of donor organ (allograft) rejection to improve patient outcomes following heart transplantation. The specific goal of this study is to determine whether daily monitoring of the transplant recipient's electrocardiogram (ECG) using a simple home device with transmission to an ECG Core Laboratory would provide an early biomarker for acute rejection. Despite routine immunosuppressant drug therapy, acute rejection is common, especially within the first 6 months following transplant surgery. To detect rejection, frequent endomyocardial biopsies of heart tissue are performed. An endomyocardial biopsy is a costly and invasive procedure performed in a hospital cardiac catheterization laboratory that has associated risks. Recent evidence suggests that acute allograft rejection causes delays in ventricular repolarization resulting in a longer QT interval on the ECG. The specific aims of the study are to: 1) determine whether an increase in the QT interval during the first 6 months following heart transplant is a sensitive and specific biomarker for acute rejection; and 2) determine the timing of QT interval increases relative to biopsy-diagnosed stages of mild/moderate/severe rejection. The potential benefit of finding a simple ECG biomarker of allograph rejection that could be measured at home is that it might yield earlier detection of rejection, allow more timely therapy and reduce mortality from acute allograft rejection.

Conditions

Cardiac Transplant Rejection; Qt Interval, Variation in

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• ≥18 years of age
• first heart transplant surgery
• not enrolled in other research studies that conflict with study design

Exclusion Criteria

• clinically unstable at time of enrollment (i.e. clinical symptoms of allograph impairment)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Belinda Chen

Project Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Drew, RN, PhD, FAAN, FAHA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Lynn Doering, RN, DNSc

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

New York Presbyterian-Columbia University Medical Center

New York, New York, United States

Countries

United States

References

Doering LV, Hickey K, Pickham D, Chen B, Drew BJ. Remote noninvasive allograft rejection monitoring for heart transplant recipients: study protocol for the novel evaluation with home electrocardiogram and remote transmission (NEW HEART) study. BMC Cardiovasc Disord. 2012 Mar 2;12:14. doi: 10.1186/1471-2261-12-14.

Reference Type: DERIVED

PMID: 22386040 (View on PubMed)

Other Identifiers

1R01NR012003-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1R01NR012003-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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