NCT01557465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

5.4 years

First QC Date

March 16, 2012

Last Update Submit

April 6, 2015

Conditions

Ischemic CardiomyopathyNonischemic CardiomyopathyHeart Failure

Outcome Measures

Primary Outcomes (1)

  • sudden arrhythmic death

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

    5 years

Secondary Outcomes (4)

  • cardiovascular mortality

    5 years

  • all-cause death

    5 years

  • appropriate ICD therapies

    5 years

  • composite heart failure endpoint

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with structural heart disease, ischemic or non-ischemic cardiomyopahty

You may qualify if:

  • structural heart disease
  • ischemic or non-ischemic cardiomyopathy

You may not qualify if:

  • pregnancy
  • age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related 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 alternans study (MAS). Circ Arrhythm Electrophysiol. 2014 Apr;7(2):259-66. doi: 10.1161/CIRCEP.113.000958. Epub 2014 Mar 1.

    PMID: 24585716RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Medicine

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 19, 2012

Study Start

November 1, 2009

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

US(1)