Heart Rate Response to Regadenoson and Sudden Cardiac Death

NCT01842035 | Completed Results DMC

• 1 other identifier: REGA 12D05
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Systolic Dysfunction; Sudden Cardiac Death

Keywords

Implantable cardiac defibrillator; regadenoson; sudden cardiac death; heart rate response

Outcome Measures

Primary Outcomes (1)

• Sudden Cardiac Death

  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.

  Until end of follow-up, median follow-up 40 months

Secondary Outcomes (5)

• All-cause Death

  Until end of follow-up, median follow-up 40 months

• First Appropriate ICD Therapy

  Until end of follow-up, median follow-up 40 months

• Inappropriate ICD Therapy

  Until end of follow-up, median follow-up 40 months

• All-cause Death or First Appropriate ICD Therapy

  Until end of follow-up, median follow-up 40 months

• Sudden Cardiac Death or Appropriate ICD Therapy

  Until end of follow-up, median follow-up 40 months

Study Arms (1)

Regadenoson

EXPERIMENTAL

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. \--------------------------------------------------------------------------------

Drug: regadenoson

Interventions

regadenoson DRUG

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.

Also known as: Lexiscan

Regadenoson

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Astellas Scientific & Medical Affairs, Inc.: collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Related Publications (5)

• Hage FG, Heo J, Franks B, Belardinelli L, Blackburn B, Wang W, Iskandrian AE. Differences in heart rate response to adenosine and regadenoson in patients with and without diabetes mellitus. Am Heart J. 2009 Apr;157(4):771-6. doi: 10.1016/j.ahj.2009.01.011. Epub 2009 Mar 6.

  PMID: 19332209 BACKGROUND

• Hage FG, Perry G, Heo J, Iskandrian AE. Blunting of the heart rate response to adenosine and regadenoson in relation to hyperglycemia and the metabolic syndrome. Am J Cardiol. 2010 Mar 15;105(6):839-43. doi: 10.1016/j.amjcard.2009.11.042.

  PMID: 20211328 BACKGROUND

• Hage FG, Dean P, Bhatia V, Iqbal F, Heo J, Iskandrian AE. The prognostic value of the heart rate response to adenosine in relation to diabetes mellitus and chronic kidney disease. Am Heart J. 2011 Aug;162(2):356-62. doi: 10.1016/j.ahj.2011.05.014. Epub 2011 Jul 18.

  PMID: 21835298 BACKGROUND

• Hage FG, Dean P, Iqbal F, Heo J, Iskandrian AE. A blunted heart rate response to regadenoson is an independent prognostic indicator in patients undergoing myocardial perfusion imaging. J Nucl Cardiol. 2011 Dec;18(6):1086-94. doi: 10.1007/s12350-011-9429-1. Epub 2011 Jul 22.

  PMID: 21785922 BACKGROUND

• Iqbal FM, Al Jaroudi W, Sanam K, Sweeney A, Heo J, Iskandrian AE, Hage FG. Reclassification of cardiovascular risk in patients with normal myocardial perfusion imaging using heart rate response to vasodilator stress. Am J Cardiol. 2013 Jan 15;111(2):190-5. doi: 10.1016/j.amjcard.2012.09.013. Epub 2012 Oct 27.

  PMID: 23111139 BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Death, Sudden, Cardiac

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The lower than planned sample size decreased the power of the study. To partially compensate, we allowed for longer than planned follow-up.

Results Point of Contact

• Title: Fadi Hage
• Organization: University of Alabama at Birmingham

fadihage@uab.edu

2059757123

Study Officials

• Fadi G Hage, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: April 29, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2022
• Last Updated: October 18, 2022
• Results First Posted: April 4, 2022

Record last verified: 2022-10

Locations

US (1)