Heart Rate Response to Regadenoson and Sudden Cardiac Death

Not Applicable

Completed

• Conditions: Left Ventricular Systolic Dysfunction; Sudden Cardiac Death
• Interventions: Drug: regadenoson

• Registration Number: NCT01842035
• Lead Sponsor: University of Alabama at Birmingham

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 Description

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:

1. A blunted heart rate response to regadenoson is an independent predictor of sudden cardiac death.

2. 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:

1. 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.

2. 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 having an ICD.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-29
• Primary Completion: 2020-04
• Results First Submitted: 2021-10-06
• Results First Submitted QC: 2022-03-11
• Results First Posted: 2022-04-04
• Study Completion: 2022-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

• Female subject who is pregnant or lactating
• Subject with active severe asthma or chronic obstructive pulmonary disease which, in the Investigator's opinion, places the subject at risk for severe bronchoconstriction
• Treatment with dipyridamole, theophylline, aminophylline or pentoxifylline within 24 hours of receiving regadenoson
• Treatment with any investigational drug within 30 days or 5 half lives - whichever is longer prior to study entry
• Subject with any prior allergic response to aminophylline or other contraindication to receiving intravenous regadenoson
• Subjects with second or third degree atrioventricular block or dependent on pacemaker
• Subject with uncontrolled severe hypertension (systolic > 200 mmHg or diastolic >120 mmHg) or pretreatment hypotension (systolic BP <90 mmHg)
• Subject with hemodynamically significant aortic stenosis or outflow tract obstruction
• Subject with decompensated heart failure (NYHA functional class IV)
• Subject with acute myocardial infarction, new onset of ischemia, percutaneous coronary intervention, or coronary artery bypass grafting within 30 days of receiving regadenoson
• Subject is on dialysis for end stage renal disease or has an estimated glomerular filtration rate < 15 mL/min
• Subjects with cardiac transplantation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regadenoson	regadenoson	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. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline. --------------------------------------------------------------------------------

Primary Outcome Measures

Name	Time	Method
Sudden Cardiac Death	Until end of follow-up, median follow-up 40 months	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.

Secondary Outcome Measures

Name	Time	Method
First Appropriate ICD Therapy	Until end of follow-up, median follow-up 40 months	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
Sudden Cardiac Death or Appropriate ICD Therapy	Until end of follow-up, median follow-up 40 months	Sudden cardiac 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
All-cause Death	Until end of follow-up, median follow-up 40 months	death from any cause
Inappropriate ICD Therapy	Until end of follow-up, median follow-up 40 months	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	Until end of follow-up, median follow-up 40 months	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

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States