ECG Optimization of CRT: Evaluation of Mid-term Response (BEST)

August 1, 2018 updated by: Elena Arbelo, Hospital Clinic of Barcelona

Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response

New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram.

In this prospective, double-blind, study, the investigators will evaluate:

Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device.

Secondary endpoints:

  1. To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device.
  2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm.
  3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups.
  4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial sensing or atrial pacing.

For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

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

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: patients with standard indication of cardiac resynchronization

  • Ejection fraction ≤35%.
  • QRS duration ≥120 ms.
  • New York Heart Association Functional Class 2-4..
  • Left ventricular diameter ≥55 mm.
  • Optimal medical treatment.

Exclusion Criteria:

  • Patient refusal.
  • Cardiopathy with a reversible cause.
  • Prevision of heart transplantation.
  • Atrial fibrillation.
  • Complete AV block.
  • AV delay >250 ms.
  • Right bundle branch block.
  • Severe peripheral vascular disease.
  • Other diseases with < 1 year life expectancy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nominal
CRT device is programmed with the nominal values.
Other: Device programming: nominal
CRT device is programmed to nominal values
Experimental: Narrow QRS
CRT device is programmed by QRS optimization
Other: Programming optimization by QRS
CRT device is programmed by QRS optimization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 12 months
Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic response
Time Frame: 12 months
Echocardiographic response: >15% decrease in LV end-systolic volume and survival without heart transplantation or death.
12 months
Pacing/sensing AV delay difference
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Study Chair: Elena Arbelo, MD, PhD, Hospital Clinic Universitari de Barcelona
  • Study Director: Lluís Mont, MD, PhD, Hospital Clinic Universitari de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2009

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimate)

September 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEST

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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