T Wave Alternans in Hemodialysis

NCT ID: NCT00296543

Last Updated: 2011-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease Coronary Heart Disease Congestive Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dialysis Clinic, Inc.

INDUSTRY

Sponsor Role collaborator

Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Indiana University School of Medicine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Allon Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0508-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Arrhythmia in Hemodialysis Patients
NCT04036695 ACTIVE_NOT_RECRUITING NA
New Needle for Two-Needle Hemodialysis
NCT01416896 UNKNOWN PHASE2/PHASE3