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Home Electrocardiogram (ECG) Monitoring After Heart Transplantation

Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01365806
Acronym
NEW HEART
Enrollment
345
Registered
2011-06-03
Start date
2011-08-31
Completion date
2016-01-31
Last updated
2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Transplant Rejection, Qt Interval, Variation in

Keywords

heart transplantation, allograft rejection, QT interval, electrocardiogram (ECG)

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.

Interventions

None listed

Sponsors

University of California, San Francisco
CollaboratorOTHER
Cedars-Sinai Medical Center
CollaboratorOTHER
Columbia University
CollaboratorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
number and grade of acute allograft rejection episodeswithin one year after transplant surgery

Secondary

MeasureTime frame
all cause mortalityone year after transplant surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026