Cardiac Strains for Optimization of CRT in Non-Responders

University Hospital Ostrava

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Device: CRT-D re-programming; Diagnostic Test: Trans-Thoracic Echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT03803826

FNO-STRAINS

Details and patient eligibility

About

The aim of this study is to investigate the possibility of optimizing the performance of CRT-D in non-responding patients through utilization of cardiac strain speckle tracking

Full description

In approximately 30% of patients, cardiac resynchronization therapy (CRT) fails to lead to any improvement of the patients' status.

In this study, an investigation of a possible method of optimization through speckle tracking of cardiac strains is attempted.

Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap and the interventricular interval subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and use of other strain combinations assessed.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with symptomatic heart failure with NYHA III/IV, pharmacological treatment options exhausted, LVEF below 30%, and QRS duration over 130ms who did not respond to the implantation of CRT-D

Exclusion criteria

• Age below 18
• response to the original CRT implantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

CRT-D re-programming

Experimental group

Description:

The ineffective previously implanted CRT-D is reprogrammed under supervision of transthoracic echocardiography to: 1. adjust the atrioventricular interval so that E and A waves do not overlap 2. the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. Transthoracic echocardiography is performed prior to optimization and 3 months after optimization (i.e., 3 and 6 months after the CRT implantation) and and New York Heart Association Classification (NYHA Classification; total score range 1-4) is being determined in accordance with the standard NYHA methods re-programming of the interventricular interval

Treatment:

Device: CRT-D re-programming

Diagnostic Test: Trans-Thoracic Echocardiography

Control Group

No Intervention group

Description:

Only trans-thoracic echocardiography is performed during follow-ups at 3 and 6 months from CRT implantations performed and New York Heart Association Classification (NYHA Classification; total score range 1-4) is being determined in accordance with the standard NYHA methods