ECG Optimization of CRT: Evaluation of Mid-term Response

Heart Failure Clinical Trial

— BEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439529
• Other study ID #: BEST
• Status: Completed
• Phase: Phase 3
• Start date: April 2009
• Est. completion date: September 2017

Study information

• Verified date: August 2018
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Device programming: nominal
CRT device is programmed to nominal values
• Programming optimization by QRS
CRT device is programmed by QRS optimization

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response	Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT.	12 months
Secondary	Echocardiographic response	Echocardiographic response: >15% decrease in LV end-systolic volume and survival without heart transplantation or death.	12 months
Secondary	Pacing/sensing AV delay difference		12 months