Mechanical Alternans Study (MAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Larisa Tereshchenko, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01557465
First received: March 16, 2012
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.


Condition
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


Estimated Enrollment: 1000
Study Start Date: November 2009
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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

Criteria

Inclusion Criteria:

  • structural heart disease
  • ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

  • pregnancy
  • age < 18 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557465

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

No publications provided

Responsible Party: Larisa Tereshchenko, Instructor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01557465     History of Changes
Other Study ID Numbers: NA_00032758
Study First Received: March 16, 2012
Last Updated: August 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Tachycardia, Ventricular
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Tachycardia
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014