Cardiac Strains for Optimization of CRT in Non-Responders

Chronic Heart Failure Clinical Trial

Official title:

Use of Cardiac Strains for Optimization of Cardiac Resynchronization Therapy in Non-Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803826
• Other study ID #: FNO-STRAINS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• CRT-D re-programming
The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to: adjust the atrioventricular interval so that E and A waves do not overlap the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.

Diagnostic Test:
• Trans-Thoracic Echocardiography
This intervention relates to the determination of strains and atrioventricular interval and supplies data for reprogramming the ineffective CRT-D Transthoracic echocardiography performed to determine the left ventricular ejection fraction as an outcome measure is not considered intervention here (as it is also performed in the control group and that would cause an error cross-referencing.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the left ventricular ejection fraction	Left ventricular ejection fraction measured by transthoracic echocardiography prior to optimizing and during a follow-up examination three month after optimizing	6 months from CRT-D implantation, 3 months from optimization
Secondary	Change in NYHA Classification	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	6 months from CRT-D implantation, 3 months from optimization