Mechanical Alternans Study

Heart Failure Clinical Trial

— MAS  

Official title:

Study of Mechanical Alternans for Prediction of Ventricular Tachyarrhythmias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557465
• Other study ID #: NA_00032758
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: April 6, 2015
• Start date: November 2009
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• structural heart disease

• ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

• pregnancy

• age < 18 years old

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Ischemic Cardiomyopathy
• Nonischemic Cardiomyopathy

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kim R, Cingolani O, Wittstein I, McLean R, Han L, Cheng K, Robinson E, Brinker J, Schulman SS, Berger RD, Henrikson CA, Tereshchenko LG. Mechanical alternans is associated with mortality in acute hospitalized heart failure: prospective mechanical alternan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sudden arrhythmic death	appropriate ICD therapy due to fast ventricular tachycardia or ventricular fibrillation, or sudden cardiac death	5 years	Yes
Secondary	cardiovascular mortality		5 years	Yes
Secondary	all-cause death		5 years	Yes
Secondary	appropriate ICD therapies	either ICD shock or antitachycardia pacing due to ventricular arrhythmia	5 years	Yes
Secondary	composite heart failure endpoint	pump-failure death, or heart transplantation, or heart failure hospitalization, whichever came first	5 years	Yes