Cardiac Strains for Optimization of CRT in Non-Responders

NCT03803826 | Completed DMC

• 1 other identifier: FNO-STRAINS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Heart Failure

Keywords

cardiac resynchronization therapy; non-responders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in NYHA Classification

  6 months from CRT-D implantation, 3 months from optimization

Study Arms (2)

CRT-D re-programming

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

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

Interventions

CRT-D re-programming DEVICE

The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) 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.

CRT-D re-programming

Trans-Thoracic Echocardiography DIAGNOSTIC_TEST

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.

CRT-D re-programming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age below 18
• response to the original CRT implantation

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, 70800, Czechia

Location

Study Officials

• David Sipula, MUDr.

  University Hospital Ostrava, Dpt of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months from implementation are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap, the interventricular interval iss 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 the use of other strain combinations assessed.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 15, 2019
• Study Start: January 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CZ (1)