Status:
COMPLETED
Heart Rate Response to Regadenoson and Sudden Cardiac Death
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Astellas Scientific & Medical Affairs, Inc.
Conditions:
Left Ventricular Systolic Dysfunction
Sudden Cardiac Death
Eligibility:
All Genders
19-80 years
Phase:
NA
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 approp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01842035
Start Date
February 1 2013
End Date
July 1 2022
Last Update
October 18 2022
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35294