Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study

Withdrawn before enrolling

Conditions studied: Advanced Heart Failure, Heart Transplantation

In brief

The purpose of this research study is to apply new non-invasive, no-risk techniques to a cardiac transplant population for assessment of their reliability in detecting heart transplant rejection. Graft rejection remains a major factor limiting long-term survival despite continued advancement in the use of immunosuppression. Aggressive surveillance for the detection of acute rejection is therefore necessary. Repeated endomyocardial biopsy (EMB) (at least 11 times the first year after transplantation) remains the only reliable surveillance method available. EMB is expensive, invasive, inconvenient to the patient, and associated with a significant incidence of serious complications. Therefore, it would be very important for patient care if new no-risk methods would prove to be effective in surveillance of rejection. This research study is designed to measure non-invasive ways to assess rejection along with the standard planned endomyocardial biopsies you will have after heart transplantation. First, the investigators plan to test the effectiveness of the investigational use of the CMI 2406 Magnetocardiograph that has been approved by the U.S Food and Drug Administration (FDA). While the device used in the study is FDA-approved for the non-invasive measurements and recordings of the heart's magnetic field reflecting the heart's electrical currents, it is not yet approved for the specific use of detection of transplant rejection.

Key facts

Study ID

NCT00572286

Run by

Cedars-Sinai Medical Center

People needed

20

Starts

2005-10-01

Expected to finish

2009-12-01

Last updated by the study team

2009-11-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who will have heart transplantation or who have had heart transplantation AND who are scheduled for surveillance biopsies

You may not qualify if…

• Patients with Pacemakers or Implantable Cardioverter-Defibrillators(ICD)
• Patients with poor echocardiographic images
• Patients with irregular atrial fibrillation

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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