Cardiac Strains for Optimization of CRT in Non-Responders

Not Applicable

Completed

• Conditions: Chronic Heart Failure

• Registration Number: NCT03803826
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2019-01-13
• Study First Posted: 2019-01-15
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the left ventricular ejection fraction	6 months from CRT-D implantation, 3 months from optimization	Left ventricular ejection fraction measured by transthoracic echocardiography prior to optimizing and during a follow-up examination three month after optimizing

Secondary Outcome Measures

Name	Time	Method
Change in NYHA Classification	6 months from CRT-D implantation, 3 months from optimization	NYHA (New York Heart Association Classification measured using the standard NYHA range I to IV - I being the best result, IV the worst) was evaluated using a standard NYHA questionnaire before optimization and 3 months after optimization during a follow-up examination

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Czechia