T Wave Alternans in Hemodialysis | NCT00296543

Studies
T Wave Alternans in Hemodialysis

NCT00296543

Sponsor

Indiana University

Status

Completed

Last Update Posted

Jun 20, 2011Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

End Stage Renal Disease
Coronary Heart Disease
Congestive 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

Jun 2011

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

Oct 2005

Primary Completion Date

Not provided

Completion Date

Aug 2008Actual

First Submitted Date

Feb 23, 2006

First Submission Date that Met QC Criteria

Feb 23, 2006

First Posted Date

Feb 27, 2006Estimated

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

Jun 17, 2011

Last Update Posted Date

Jun 20, 2011Estimated

Name	Class
Dialysis Clinic, Inc.	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients.

Detailed Description

One-third to one-quarter of hemodialysis patients die of sudden cardiac death (SCD). The hemodialysis procedure may theoretically increase the risk of SCD. This study uses T wave alternans, a noninvasive marker of SCD, to objectively determine whether the hemodialysis procedure alters the risk of SCD in hemodialysis patients.

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

30Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Normal sinus rhythm

Exclusion Criteria:

Inability to give written informed consent
Active cardiac ischemia
Pacemaker
Inability to perform a brief walking treadmill test

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

Hemodialysis patients with heart disease and/or poor cardiac function

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allon Friedman, MD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University School of Medicine		Indianapolis	Indiana	46032	United States

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D003327	Coronary Disease
D006333	Heart Failure
D016757	Death, Sudden, Cardiac

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided