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Completed

NCT Number: NCT01557465

Mechanical Alternans Study

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.

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Key information

Conditions

Ischemic Cardiomyopathy Cardiovascular Diseases Heart Diseases Heart Failure Nonischemic Cardiomyopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • structural heart disease
  • ischemic or non-ischemic cardiomyopathy

Exclusion criteria

  • pregnancy
  • age < 18 years old

Treatment and study plan

Primary outcomes

  1. sudden arrhythmic death

    Time frame: 5 years

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Study of Mechanical Alternans for Prediction of Ventricular Tachyarrhythmias

Acronym: MAS

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2012
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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