Mechanical Alternans Study

Completed

• Conditions: Heart Failure; Nonischemic Cardiomyopathy; Ischemic Cardiomyopathy

• Registration Number: NCT01557465
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to determine whether mechanical alternans (alternating strong and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies, and to predict progression of heart failure and death.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• structural heart disease
• ischemic or non-ischemic cardiomyopathy

Exclusion Criteria

• pregnancy
• age < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sudden arrhythmic death	5 years	appropriate ICD therapy due to fast ventricular tachycardia or ventricular fibrillation, or sudden cardiac death

Secondary Outcome Measures

Name	Time	Method
appropriate ICD therapies	5 years	either ICD shock or antitachycardia pacing due to ventricular arrhythmia
cardiovascular mortality	5 years
all-cause death	5 years
composite heart failure endpoint	5 years	pump-failure death, or heart transplantation, or heart failure hospitalization, whichever came first

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States