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Clinical Trials/NCT01557465
NCT01557465
Completed
Not Applicable

Study of Mechanical Alternans for Prediction of Ventricular Tachyarrhythmias

Johns Hopkins University1 site in 1 country134 target enrollmentStarted: November 2009Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
134
Locations
1
Primary Endpoint
sudden arrhythmic death

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • structural heart disease
  • ischemic or non-ischemic cardiomyopathy

Exclusion Criteria

  • pregnancy
  • age \< 18 years old

Outcomes

Primary Outcomes

sudden arrhythmic death

Time Frame: 5 years

appropriate ICD therapy due to fast ventricular tachycardia or ventricular fibrillation, or sudden cardiac death

Secondary Outcomes

  • appropriate ICD therapies(5 years)
  • cardiovascular mortality(5 years)
  • all-cause death(5 years)
  • composite heart failure endpoint(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Larisa Tereshchenko

Instructor of Medicine

Johns Hopkins University

Study Sites (1)

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