Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy (RER-CRT)

August 29, 2022 updated by: Johns Hopkins University

Study of Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy

Cardiac resynchronization therapy with pacemaker alone, or in combination with a cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS duration 6 months after cardiac resynchronization therapy. Such phenomenon is called reverse electrical remodeling of native conduction. Retrospective analysis showed that reverse electrical remodeling of the native conduction after at least 6 months of CRT is associated with decreased rate of ventricular arrhythmias and better survival. This study is designed to study reverse electrical remodeling prospectively.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Heart Failure Patients undergoing implantation of cardiac resynchronization therapy defibrillator

Description

Inclusion Criteria:

  • patients undergoing implantation of a CRT-D

Exclusion Criteria:

  • age < 18 y
  • pregnancy or planned pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CRT
Patients with implanted cardiac resynchronization therapy defibrillator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between electrical and mechanical remodeling
Time Frame: 6 months after CRT implantation
correlation between electrical and mechanical measures of dyssynchrony
6 months after CRT implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Larisa Tereshchenko, MD, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 14, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00065477

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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