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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Larisa Tereshchenko, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01924221
First received: August 14, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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 fenomenon 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.


Condition Intervention
Heart Failure.
An Approved Indication Per ACC/AHA/HRS Guidelines for Implantation of a Cardiac Resynchronization Therapy Defibrillator
Other: this is an observational study. No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Sustained ventricular tachyarrhythmias [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart Failure Hospitalizations [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • All-cause mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2011
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CRT
Patients with implanted cardiac resynchronization therapy defibrillator
Other: this is an observational study. No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Heart Failure Patients with currently approved indications for implantation of cardiac resynchronization therapy defibrillator

Criteria

Inclusion Criteria:

  • an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D

Exclusion Criteria:

  • age < 18 y
  • pregnancy or planned pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924221

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Larisa Tereshchenko, Instructor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01924221     History of Changes
Other Study ID Numbers: RER CRT, NA_00065477
Study First Received: August 14, 2013
Last Updated: August 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Remodeling
Heart Failure
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014