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Cardiac Strains for Optimization of CRT in Non-Responders

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
CRT-D re-programming
Trans-Thoracic Echocardiography
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring cardiac resynchronization therapy, non-responders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CRT-D re-programming

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2018
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT03803826
Brief Title
Cardiac Strains for Optimization of CRT in Non-Responders
Official Title
Use of Cardiac Strains for Optimization of Cardiac Resynchronization Therapy in Non-Responders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
cardiac resynchronization therapy, non-responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-D re-programming
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm 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
Intervention Type
Device
Intervention Name(s)
CRT-D re-programming
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Trans-Thoracic Echocardiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the left ventricular ejection fraction
Description
Left ventricular ejection fraction measured by transthoracic echocardiography prior to optimizing and during a follow-up examination three month after optimizing
Time Frame
6 months from CRT-D implantation, 3 months from optimization
Secondary Outcome Measure Information:
Title
Change in NYHA Classification
Description
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
Time Frame
6 months from CRT-D implantation, 3 months from optimization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sipula, MUDr.
Organizational Affiliation
University Hospital Ostrava, Dpt of Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
ZIP/Postal Code
70800
Country
Czechia

12. IPD Sharing Statement

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Cardiac Strains for Optimization of CRT in Non-Responders

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