Home Electrocardiogram (ECG) Monitoring After Heart Transplantation (NEW HEART)
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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. |
ClinicalTrials.gov Identifier: NCT01365806 |
Recruitment Status :
Completed
First Posted : June 3, 2011
Last Update Posted : March 8, 2017
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Condition or disease |
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Cardiac Transplant Rejection Qt Interval, Variation in |
Study Type : | Observational |
Actual Enrollment : | 345 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | January 2016 |

- number and grade of acute allograft rejection episodes [ Time Frame: within one year after transplant surgery ]
- all cause mortality [ Time Frame: one year after transplant surgery ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

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 ClinicalTrials.gov identifier (NCT number): NCT01365806
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
University of California, Los Angeles (UCLA) | |
Los Angeles, California, United States, 90095 | |
United States, New York | |
New York Presbyterian-Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Barbara Drew, RN, PhD, FAAN, FAHA | University of California, San Francisco | |
Principal Investigator: | Lynn Doering, RN, DNSc | University of California, Los Angeles |
Responsible Party: | Belinda Chen, Project Director, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT01365806 |
Other Study ID Numbers: |
1R01NR012003-01A1 ( U.S. NIH Grant/Contract ) 1R01NR012003-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | June 3, 2011 Key Record Dates |
Last Update Posted: | March 8, 2017 |
Last Verified: | March 2017 |
heart transplantation allograft rejection QT interval electrocardiogram (ECG) |