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Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure (RESET-CRT)

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ClinicalTrials.gov Identifier: NCT03494933
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Heart Center Leipzig - University Hospital
Information provided by (Responsible Party):
Leipzig Heart Institute GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Procedure: CRT-P implantation Procedure: CRT-D implantation Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure - An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial Without Investigational Medical Products (Proof of Strategy Trial)
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CRT-P group
Intervention: CRT-P implantation
Procedure: CRT-P implantation
Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure and will receive on top a CRT-P device.

Active Comparator: CRT-D group
Intervention: CRT-D implantation
Procedure: CRT-D implantation
Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure and will receive on top a CRT-D device.




Primary Outcome Measures :
  1. Time from randomisation to the occurrence of all-cause death [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]

Secondary Outcome Measures :
  1. Time from randomisation to death from cardiac causes [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]
  2. Time from randomisation to sudden cardiac death [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]
  3. Time from randomisation to life-threatening arrhythmias [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]
  4. Time from randomisation to first composite of Major Adverse Cardiac Event (MACE) [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]
  5. Time from randomisation to first hospitalisation for cardiac causes [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]
  6. Nights spent in hospital for cardiac causes per year of follow-up [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]
    Number of nights spent in hospital is calculated as time difference in days from hospital discharge to hospital admission. All hospital stays are serious adverse event by definition and will be assessed by an independent Endpoint Review Committee. The Endpoint Review Committee will also evaluate if a hospital stay for cardiac cause is given. Per year of follow-up refers to a calculated number related to total follow-up duration of each patient normalised to years of follow-up.

  7. Number of hospital readmissions for cardiac causes after randomisation [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]
  8. Changes in quality of life (EQ-5D) comparing baseline with 12 and 24 months [ Time Frame: at baseline, 12 and 24 months after randomisation ]
    Quality of life will be measured using the European Quality of life 5 Dimension (EQ5D) questionnaire. Scores range from 0-15 where 15 is the worst score.

  9. Total cost of treatment as compound endpoint of MACEs, number of hospital days for cardiac causes and ambulatory visits for cardiac causes [ Time Frame: Randomization to end of study (event-driven, expected about 10 months after last patient in) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494933


Contacts
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Contact: Gerhard Hindricks, MD +49 341 865 1410 Gerhard.Hindricks@helios-gesundheit.de
Contact: Nikolaos Dagres, MD +49 341 865 252612

Locations
Show Show 91 study locations
Sponsors and Collaborators
Leipzig Heart Institute GmbH
Heart Center Leipzig - University Hospital
Investigators
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Principal Investigator: Gerhard Hindricks, MD Heart Center Leipzig - University Hospital
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Responsible Party: Leipzig Heart Institute GmbH
ClinicalTrials.gov Identifier: NCT03494933    
Other Study ID Numbers: HRC048864
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases