Heart Rate Response to Regadenoson and Sudden Cardiac Death

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Astellas Scientific & Medical Affairs, Inc.
• Treatments: Regadenoson

Criteria

Inclusion criteria:

• 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.

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