Heart Rate Response to Regadenoson and Sudden Cardiac Death

Completed · Not applicable

Conditions studied: Left Ventricular Systolic Dysfunction, Sudden Cardiac Death

In brief

The purpose of this study is to determine whether a blunted heart rate response to regadenoson is an independent predictor of sudden cardiac death.

Key facts

Study ID: NCT01842035
Run by: University of Alabama at Birmingham
People needed: 90
Starts: 2013-02-01
Expected to finish: 2022-07-01
Last updated by the study team: 2022-10-18

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 19-80 years
Female subjects must be (a) at least one year post-menopause or surgically sterile or (b) be non-pregnant and (c) non-lactating.
Subject must be able and willing to provide written informed consent
Subject must be referred for a clinically indicated ICD and fall into one of the following groups:
subjects with left ventricular ejection fraction less than 35% due to prior myocardial infarction who are at least 40 days post-myocardial infarction and are in NYHA functional Class II or III.
subjects with non-ischemic dilated cardiomyopathy who have a left ventricular ejection fraction less than or equal to 35% and who are in NYHA functional Class II or III.
Subjects with left ventricular dysfunction due to prior myocardial infarction who are at least 40 days post-myocardial infarction, have a left ventricular ejection fraction less than 30%, and are in NYHA functional Class I.

You may not qualify if…

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

Where it is running

UAB — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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