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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Elena Arbelo, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01439529
First received: September 19, 2011
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure
Other: Device programming: nominal
Other: Programming optimization by QRS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Clinical response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT.


Secondary Outcome Measures:
  • Echocardiographic response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Echocardiographic response: >15% decrease in LV end-systolic volume and survival without heart transplantation or death.

  • Pacing/sensing AV delay difference [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01439529

Contacts
Contact: Elena Arbelo, MD, PhD +3493227551 earbelo@clinic.ub.es
Contact: Lluis Mont, MD, PhD +3493227551 lmont@clinic.ub.es

Locations
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Elena Arbelo, MD, PhD    +3493227551    earbelo@clinic.ub.es   
Contact: Lluis Mont, MD, PhD    +3493227551    lmont@clinic.ub.es   
Principal Investigator: Elena Arbelo, MD, PhD         
Principal Investigator: Lluis Mont, MD, PhD         
Sub-Investigator: Emilce Trucco, MD         
Sub-Investigator: Roger Borras, BSc         
Sub-Investigator: Angeles Castel, MD         
Sub-Investigator: David Tamborero, B Eng         
Sub-Investigator: José M Tolosana, MD         
Sub-Investigator: Adelina Doltra, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Study Chair: Elena Arbelo, MD, PhD Hospital Clinic Universitari de Barcelona
Study Director: Lluís Mont, MD, PhD Hospital Clínic Universitari de Barcelona
  More Information

No publications provided

Responsible Party: Elena Arbelo, Coordinator of the AF programme, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01439529     History of Changes
Other Study ID Numbers: BEST
Study First Received: September 19, 2011
Last Updated: March 17, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:
Cardiac
Resynchronization
Therapy

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014