Mechanical Alternans Study | NCT01557465

Studies
Mechanical Alternans Study

NCT01557465

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Apr 8, 2015Estimated

Enrollment

134Actual

Phase

Not provided

Conditions

Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy
Heart Failure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Mar 16, 2012

First Submission Date that Met QC Criteria

Mar 16, 2012

First Posted Date

Mar 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sudden arrhythmic death	appropriate ICD therapy due to fast ventricular tachycardia or ventricular fibrillation, or sudden cardiac death	5 years

Secondary Outcomes

Measure	Description	Time Frame
cardiovascular mortality		5 years
all-cause death		5 years
appropriate ICD therapies

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

structural heart disease
ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

pregnancy
age < 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University School of Medicine		Baltimore	Maryland	21205	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24585716	Result	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases