Clinical trial NCT01439529: ECG Optimization of CRT: Evaluation of Mid-term Response
Official title: Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Cardiac
Resynchronization
Therapy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


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

Primary outcomes:
measure: Clinical response
timeFrame: 12 months
Secondary outcomes:
measure: Echocardiographic response
timeFrame: 12 months
measure: Pacing/sensing AV delay difference
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic Universitari de Barcelona
name: Elena Arbelo, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Clínic Universitari de Barcelona
name: Lluís Mont, MD, PhD
role: STUDY_DIRECTOR
References:
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.