Clinical Trial: Heart Rate Response to Regadenoson and Sudden Cardiac Death
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Heart Rate Response to Regadenoson and Sudden Cardiac Death
Brief Summary: The purpose of this study is to determine whether a blunted heart rate response to regadenoson is an independent predictor of sudden cardiac death.
Detailed Summary:
In patients with heart failure and in those with a history of sudden cardiac death, an Implantable Cardiac Defibrillator (ICD) reduces death rates. However, not all patients with an ICD receive appropriate therapy from it. Inappropriate ICD shocks are common and are associated with worse quality of life and increased death rate. We hope to establish a better predictor of risk of sudden cardiac death and of response to ICD. We are conducting a prospective observational study of 150 patients (18-80 years) with an indication for ICD implantation for primary prevention of sudden cardiac death. Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush.
The main objectives of this proposal are to investigate whether:
- A blunted heart rate response to regadenoson is an independent predictor of sudden cardiac death.
- A blunted heart rate response to regadenoson can be used as a predictor of response to ICD on top of traditionally used indicators.
We Hypothesize that:
- Patients with a blunted heart rate response to regadenoson are at higher risk of sudden cardiac death (death or appropriate cardiac defibrillation). This risk is maintained after controlling for age, gender, left ventricular ejection fraction, heart failure symptoms and medication use.
- Patients with a normal heart rate response to regadenoson have a low rate of events (death or appropriate cardiac defibrillation) despite meeting current indications for
Sponsor: University of Alabama at Birmingham
Current Primary Outcome: Sudden cardiac death [ Time Frame: two years from the time of ICD implantation ]
Sudden cardiac death will be defined as death within 1 hour of symptom onset, or an unobserved death in which the patient was seen and known to be doing well within 24 hours of death. Survivors of aborted sudden cardiac death, resuscitated cardiac arrest, and those receiving appropriate ICD therapy will also be considered to have experienced sudden cardiac death and will be included in the primary end point.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- all-cause death [ Time Frame: 2-years from the time of ICD implantation ]death by any cause 2 years from the time of ICD implantation
- First appropriate ICD therapy [ Time Frame: 2 years from time of ICD implantation ]antitachycardia pacing therapy or shock for tachyarrhythmia determined by evaluation of the clinical information and by device diagnostics to be either ventricular fibrillation or ventricular tachycardia
- Inappropriate ICD therapy [ Time Frame: 2 years from time of ICD implantation ]unnecessary antitachycardia pacing or shock delivered by the ICD for a rhythm that is not a true ventricular fibrillation or ventricular tachycardia
- All-cause death or first appropriate ICD therapy [ Time Frame: 2 years from time of ICD implantation ]death or antitachycardia pacing therapy or shock for tachyarrhythmia determined by evaluation of the clinical information and by device diagnostics to be either ventricular fibrillation or ventricular tachycardia
- supraventricular tachycardia [ Time Frame: 2-years from the time of ICD implantation ]
Original Secondary Outcome: Same as current
Information By: University of Alabama at Birmingham
Dates:
Date Received: March 13, 2013
Date Started: February 2013
Date Completion: December 2018
Last Updated: March 17, 2017
Last Verified: March 2017
- all-cause death [ Time Frame: 2-years from the time of ICD implantation ]
