ECG Optimization of CRT: Evaluation of Mid-term Response (BEST)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Device programming: nominal
Programming optimization by QRS
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac, Resynchronization, Therapy
Eligibility Criteria
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
Sites / Locations
- Hospital Clinic de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nominal
Narrow QRS
Arm Description
CRT device is programmed with the nominal values.
CRT device is programmed by QRS optimization
Outcomes
Primary Outcome Measures
Clinical response
Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT.
Secondary Outcome Measures
Echocardiographic response
Echocardiographic response: >15% decrease in LV end-systolic volume and survival without heart transplantation or death.
Pacing/sensing AV delay difference
Full Information
NCT ID
NCT01439529
First Posted
September 19, 2011
Last Updated
August 1, 2018
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT01439529
Brief Title
ECG Optimization of CRT: Evaluation of Mid-term Response
Acronym
BEST
Official Title
Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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:
To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device.
To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm.
To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac, Resynchronization, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nominal
Arm Type
Active Comparator
Arm Description
CRT device is programmed with the nominal values.
Arm Title
Narrow QRS
Arm Type
Experimental
Arm Description
CRT device is programmed by QRS optimization
Intervention Type
Other
Intervention Name(s)
Device programming: nominal
Intervention Description
CRT device is programmed to nominal values
Intervention Type
Other
Intervention Name(s)
Programming optimization by QRS
Intervention Description
CRT device is programmed by QRS optimization
Primary Outcome Measure Information:
Title
Clinical response
Description
Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Echocardiographic response
Description
Echocardiographic response: >15% decrease in LV end-systolic volume and survival without heart transplantation or death.
Time Frame
12 months
Title
Pacing/sensing AV delay difference
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Arbelo, MD, PhD
Organizational Affiliation
Hospital Clinic Universitari de Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lluís Mont, MD, PhD
Organizational Affiliation
Hospital Clínic Universitari de Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29749935
Citation
Trucco E, Tolosana JM, Arbelo E, Doltra A, Castel MA, Benito E, Borras R, Guasch E, Vidorreta S, Vidal B, Montserrat S, Sitges M, Berruezo A, Brugada J, Mont L. Improvement of Reverse Remodeling Using Electrocardiogram Fusion-Optimized Intervals in Cardiac Resynchronization Therapy: A Randomized Study. JACC Clin Electrophysiol. 2018 Feb;4(2):181-189. doi: 10.1016/j.jacep.2017.11.020. Epub 2018 Feb 1.
Results Reference
derived
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ECG Optimization of CRT: Evaluation of Mid-term Response
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