N/A
N=90
Heart Rate Response to Regadenoson and Sudden Cardiac Death
Left Ventricular Systolic Dysfunction · Sudden Cardiac Death
Bottom Line
View on ClinicalTrials.gov: NCT01842035 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Sudden Cardiac Death — 2; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- regadenoson (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sudden Cardiac Death |
2; 6 | — |
| SECONDARY All-cause Death |
8; 8 | — |
| SECONDARY First Appropriate ICD Therapy |
6; 12 | — |
| SECONDARY Inappropriate ICD Therapy |
3; 2 | — |
| SECONDARY All-cause Death or First Appropriate ICD Therapy |
13; 16 | — |
| SECONDARY Sudden Cardiac Death or Appropriate ICD Therapy |
8; 15 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01842035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.