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Mechanical Alternans Study (MAS)

This study has been completed.
Information provided by (Responsible Party):
Larisa Tereshchenko, Johns Hopkins University Identifier:
First received: March 16, 2012
Last updated: April 6, 2015
Last verified: April 2015
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.

Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Mechanical Alternans for Prediction of Ventricular Tachyarrhythmias

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • sudden arrhythmic death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    appropriate ICD therapy due to fast ventricular tachycardia or ventricular fibrillation, or sudden cardiac death

Secondary Outcome Measures:
  • cardiovascular mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • all-cause death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • appropriate ICD therapies [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    either ICD shock or antitachycardia pacing due to ventricular arrhythmia

  • composite heart failure endpoint [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    pump-failure death, or heart transplantation, or heart failure hospitalization, whichever came first

Enrollment: 134
Study Start Date: November 2009
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with structural heart disease, ischemic or non-ischemic cardiomyopahty

Inclusion Criteria:

  • structural heart disease
  • ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

  • pregnancy
  • age < 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01557465

United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
  More Information

Responsible Party: Larisa Tereshchenko, Instructor of Medicine, Johns Hopkins University Identifier: NCT01557465     History of Changes
Other Study ID Numbers: NA_00032758 
Study First Received: March 16, 2012
Last Updated: April 6, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on October 21, 2016