Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure

  • STATUS
    Recruiting
  • End date
    Apr 30, 2022
  • participants needed
    1800
  • sponsor
    Leipzig Heart Institute GmbH
Updated on 5 November 2020
Investigator
Gerhard Hindricks, MD
Primary Contact
Universit tsklinikum Erlangen (8.7 mi away) Contact
+334 other location
medical therapy
ejection fraction
cardiomyopathy
cardiac resynchronization therapy

Summary

The objective of the study is to demonstrate that in patients with chronic heart failure who receive optimal medical treatment for this condition and have indication for Cardiac Resynchronisation Therapy, the implantation of a pacemaker (index group) is not inferior to defibrillator (control group) with respect to all-cause mortality.

Description

Heart failure is a leading cause of death, hospitalisation, impaired quality of life and health expenditure. Symptoms and survival can be significantly improved by implantation of a device for Cardiac Resynchronisation Therapy (CRT). CRT devices are available as biventricular pacemakers (CRT-P) or as significantly more complex and cost-intensive biventricular defibrillators (CRT-D).

In patients who have previously experienced a life-threatening arrhythmia, the choice of the CRT-D (and not the CRT-P) is imperative but these are a small minority of patients. For the vast majority of patients receiving CRT therapy, there is currently considerable uncertainty as to whether the defibrillator function is needed and whether its benefits outweigh its risks. The defibrillator function may protect patients from sudden cardiac death. On the other hand, device-associated complications such as device infections appear to be increased; furthermore the defibrillator comes along with specific adverse events, particularly inappropriate shocks. These shocks are common and not only traumatic to patients (potentially leading to post-traumatic stress syndrome, anxiety disorders and depression), they also are negatively associated with overall survival.

The objective of the trial is to demonstrate that in patients with chronic heart failure who receive optimal medical treatment for this condition and have indication for CRT, the implantation of a CRT-P (index group) is not inferior to CRT-D (control group) with respect to all-cause mortality. Patients with an indication for CRT will be randomised to CRT-P or CRT-D.

RESET-CRT is an event-driven trial with a planned number of randomised and treated patients of n=1,800 and of 361 primary endpoints within an estimated median follow-up period of 1.69 years.

No investigational medical product is defined to be used within RESET-CRT since only the therapeutic strategy (CRT-D versus CRT-P) is a pre-defined study treatment and allocated by random group (Proof of Strategy Trial). The devices to be implanted will be decided by the treating physician on the basis of the situation of the individual study patient and in line with local policies in routine clinical care.

Total study duration:

Enrolment of 35 months. All patients will be followed until 361 valid primary endpoints are reached (event-driven trial) which is expected about 10 months after last patient in. Total study duration of 45 months (about 4 years) is expected which might be adapted based on blinded interim analysis of the overall occurrence of the primary endpoint.

Individual study duration:

Expected mean follow-up time will be about 1.69 years per patient with a minimum follow-up time of 10 months and a maximum follow-up time of presumably 45 months.

Details
Treatment CRT-D Implantation, CRT-P Implantation
Clinical Study IdentifierNCT03494933
SponsorLeipzig Heart Institute GmbH
Last Modified on5 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic Heart Failure?
Age 18 years
Symptomatic chronic heart failure due to ischemic or non-ischemic cardiomyopathy with NYHA class II, III or ambulatory IV
Reduced left ventricular ejection fraction 35% in transthoracic echocardiography
On Optimal Medical Therapy (OMT) for at least 3 months prior to enrolment
Class I or IIa indication for implantation of an active device for cardiac resynchronisation therapy (according to 2016 Guidelines of the European Society of Cardiology for the diagnosis and treatment of acute and chronic heart failure)
Signed informed consent

Exclusion Criteria

Class I or IIa indication for implantation of an ICD for secondary prevention of sudden cardiac death and ventricular tachycardia (according to the 2015 Guidelines of the European Society of Cardiology for the management of patients with ven-tricular arrhythmias and the prevention of sudden cardiac death)
Indication for implantation of a cardiac pacemaker due to bradycardia (according to the 2013 Guidelines of the European Society of Cardiology on cardiac pacing and cardiac resynchronization therapy)
Ventricular tachycardia induced in an electrophysiological study
Carrying any implanted cardiac pacemaker, defibrillator or CRT device
Unexplained syncope
Hospitalised with unstable heart failure with NYHA class IV within 1 month prior to enrolment
Acute coronary syndrome or cardiac revascularization therapy by coronary angioplasty or coronary ar-tery bypass grafting within 3 months prior to enrolment
Cardiac valve surgery or percutaneous cardiac valvular intervention such as transcatheter aortic valve replacement or transcatheter mitral valve repair performed within 3 months prior to enrolment
Reversible non-ischemic cardiomyopathy such as acute viral myocarditis or discontinuation of alcohol in alcohol-induced heart disease
On the waiting list for heart transplant
Any disease that limits life expectancy to less than 2 years
Severe chronic renal disease (GFR<15 ml/min and/or the need for dialysis)
Participation in another clinical trial, either within the past 3 months or still ongoing (participation in sub-studies connected to this trial is permitted)
Previous participation in RESET-CRT
Pregnant women or women of childbearing potential not on adequate birth control
Drug abuse or clinically manifest alcohol abuse
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