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Mechanical Alternans Study (MAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01557465
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Ischemic Cardiomyopathy Nonischemic Cardiomyopathy Heart Failure

Study Design

Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Mechanical Alternans for Prediction of Ventricular Tachyarrhythmias
Study Start Date : November 2009
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. sudden arrhythmic death [ Time Frame: 5 years ]
    appropriate ICD therapy due to fast ventricular tachycardia or ventricular fibrillation, or sudden cardiac death


Secondary Outcome Measures :
  1. cardiovascular mortality [ Time Frame: 5 years ]
  2. all-cause death [ Time Frame: 5 years ]
  3. appropriate ICD therapies [ Time Frame: 5 years ]
    either ICD shock or antitachycardia pacing due to ventricular arrhythmia

  4. composite heart failure endpoint [ Time Frame: 5 years ]
    pump-failure death, or heart transplantation, or heart failure hospitalization, whichever came first


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557465


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

Publications:
Responsible Party: Larisa Tereshchenko, Instructor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01557465     History of Changes
Other Study ID Numbers: NA_00032758
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases