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Completed

NCT Number: NCT03803826

Cardiac Strains for Optimization of CRT 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

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, 70800, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRT-D re-programming

Device

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.

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.

Primary outcomes

  1. Change in the left ventricular ejection fraction

    Time frame: 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 outcomes

  1. Change in NYHA Classification

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 15, 2019
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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