Cardiac Strains for Optimization of CRT in Non-Responders

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: CRT-D re-programming; Diagnostic test: Trans-Thoracic Echocardiography

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Ostrava, Czechia, 70800
    • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRT-D re-programming; The ineffective previously implanted CRT-D is reprogrammed under supervision of transthoracic echocardiography 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. 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	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.
No Intervention: Control Group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: David Sipula, MUDr., University Hospital Ostrava, Dpt of Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: January 13, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; non-responders
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: FNO-STRAINS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No