Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03494933
Other study ID # HRC048864
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date February 21, 2023

Study information

Verified date August 2022
Source Helios Health Institute GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 at least n=1,356 (maximum of 2,004) and of 361 primary endpoints within an estimated median follow-up period of about 29 to 40 months. 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. Duration of study period: Enrolment of 1,356 patients is expected to be completed within 52 months after inclusion of the first patient, i.e., by 31 December 2022. With an overall annual event rate between 9.0% and 12.5%, 361 primary endpoints will have occurred within 9 to 20 months of randomisation of the last patient (between 30 September 2023 and 31 August 2024). Under these circumstances, the total study duration will be between 62 and 73 months. The Steering Committee of the study might prolong the recruitment period, for instance by 12 months, in the event of an unexpected slower recruitment rate or an overall event rate < 9.0% for the primary endpoint. For individual patients, the expected median follow-up time is between 29 and 40 months, with a minimum between 9 and 20 months and a maximum between 61 and 72 months. Follow-up may be prolonged by 12 months in the event of a prolonged recruitment period.


Recruitment information / eligibility

Status Terminated
Enrollment 959
Est. completion date February 21, 2023
Est. primary completion date February 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 (TTE) or cardiac magnetic resonance imaging (MRI) assessed verifiably within 4 weeks prior to or on the day of enrolment. - On Optimal Medical Therapy (OMT) for at least 3 months prior to enrolment. - Class I or IIa indication for implantation of a 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). - Violation of Instruction For Use of the selected device by at least one of the random group treatments. - 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 artery bypass grafting within 6 weeks 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 and participation in observational studies 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Germany Helios Klinikum Aue Aue
Germany Zentralklinik Bad Berka Bad Berka
Germany Universitäts-Herzzentrum Bad Krozingen
Germany Marienhaus Klinikum im Kreis Ahrweiler Bad Neuenahr-Ahrweiler
Germany RHÖN-KLINIKUM Campus Bad Neustadt Bad Neustadt a.d. Saale
Germany Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum Bad Oeynhausen
Germany Segeberger Kliniken Bad Segeberg
Germany Maria-Hilf-Krankenhaus Bergheim Bergheim
Germany Charité Campus Virchow-Klinikum Berlin
Germany Helios Klinikum Berlin-Buch Berlin
Germany Helios Klinikum Emil von Behring Berlin
Germany Jüdisches Krankenhaus Berlin Berlin
Germany Sana Klinikum Lichtenberg Berlin
Germany Unfallkrankenhaus Berlin Berlin
Germany Vivantes Klinikum Spandau Berlin
Germany Immanuel Klinikum Bernau - Herzzentrum Brandenburg Bernau bei Berlin
Germany Klinikum Bielefeld Bielefeld
Germany Augusta Kliniken Bochum Bochum
Germany Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
Germany Universitätsklinikum Bonn Bonn
Germany Knappschaftskrankenhaus Bottrop Bottrop
Germany REGIOMED-KLINIKEN Klinikum Coburg Coburg
Germany Carl-Thiem-Klinikum Cottbus
Germany Helios Amper-Klinikum Dachau Dachau
Germany Klinikum Lippe Detmold Detmold
Germany Herz Zentrum Westfalen - Knappschaftskrankenhaus Dortmund Dortmund
Germany St.-Johannes-Hospital Dortmund Dortmund
Germany Herzzentrum Dresden Universitätsklinik Dresden
Germany Praxisklinik Herz und Gefäße Dresden
Germany Helios Klinikum Erfurt Erfurt
Germany Hermann-Josef-Krankenhaus Erkelenz Erkelenz
Germany Universitätsklinikum Erlangen Erlangen
Germany Contilia Herz- und Gefäßzentrum Essen
Germany Ev.-Luth. Diakonissenanstalt zu Flensburg Flensburg
Germany Universitätsklinikum Frankfurt Frankfurt am Main
Germany Kreiskrankenhaus Freiberg Freiberg
Germany Klinikum Fulda Fulda
Germany UKGM - Universitätsklinikum Gießen Gießen
Germany Asklepios Harzklinik Goslar Goslar
Germany Helios Klinikum Gotha Gotha
Germany Universitätsmedizin Göttingen Göttingen
Germany Universitätsmedizin Greifswald Greifswald
Germany Klinikum Gütersloh gGmbH Gütersloh
Germany Evangelisches Krankenhaus Hagen-Haspe Hagen
Germany Krankenhaus Martha-Maria Halle-Dölau Halle (Saale)
Germany Universitätsklinikum Halle (Saale) Halle (Saale)
Germany Albertinen Herz- und Gefäßzentrum - Albertinen Krankenhaus Hamburg
Germany Asklepios Kliniken Hamburg GmbH Hamburg
Germany Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf (UKE) Hamburg
Germany St. Marien-Hospital Hamm Hamm
Germany Medizinische Hochschule Hannover (MHH) Hannover
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Helios St. Marienberg Klinik Helmstedt Helmstedt
Germany Oberhavel Kliniken Hennigsdorf
Germany Helios Klinikum Hildesheim Hildesheim
Germany Universitätsklinikum des Saarlandes Homburg
Germany Klinikum Ingolstadt Ingolstadt
Germany Universitätsklinikum Jena Jena
Germany Westpfalz-Klinikum GmbH Kaiserslautern
Germany Städtisches Klinikum Karlsruhe Karlsruhe
Germany B. Braun Ambulantes Herzzentrum Kassel Kassel
Germany Städtisches Krankenhaus Kiel Kiel
Germany Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel
Germany Katholisches Klinikum Koblenz - Montabaur Koblenz
Germany Herzzentrum Uniklinik Köln Köln
Germany Krankenhaus Porz am Rhein Köln
Germany St. Vinzenz-Hospital Köln
Germany Helios Klinikum Krefeld Krefeld
Germany Herzzentrum Leipzig Leipzig
Germany Universitätsklinikum Leipzig Leipzig
Germany Klinikum Leverkusen Leverkusen
Germany Universitätsklinikum Schleswig-Holstein Lübeck
Germany Klinikum Lüdenscheid Lüdenscheid
Germany Cardio Centrum Ludwigburg Ludwigsburg
Germany St.-Marien-Hospital Lünen Lünen
Germany Universitätsklinikum Magdeburg Magdeburg
Germany Johannes Wesling Klinikum Minden Minden
Germany Ev. Krankenhaus Bethesda Mönchengladbach Mönchengladbach
Germany Kliniken Maria Hilf Mönchengladbach
Germany Städtische Kliniken Mönchengladbach - Elisabeth-Krankenhaus Rheydt Mönchengladbach
Germany Klinik Augustinum München
Germany LMU Klinikum München
Germany München Klinik Neuperlach München
Germany Technische Universität München München
Germany Universitätsklinikum Münster Münster
Germany Havelland Kliniken Nauen
Germany Marienhaus Klinikum St. Elisabeth Neuwied Neuwied
Germany Klinikum Nürnberg Süd Nürnberg
Germany St. Vincenz-Krankenhaus Paderborn
Germany Helios Vogtland-Klinikum Plauen Plauen
Germany Harzklinikum Dorothea Christiane Erxleben Klinikum Quedlinburg Quedlinburg
Germany Elblandklinikum Riesa Riesa
Germany Universitätsmedizin Rostock Rostock
Germany Asklepios Klinikum Uckermark Schwedt/Oder
Germany Helios Kliniken Schwerin Schwerin
Germany Helios Klinikum Siegburg Siegburg
Germany Diakonie Klinikum Jung-Stilling Siegen
Germany Marien Kliniken Siegen
Germany Krankenhaus Maria-Hilf Stadtlohn Klinikum Westmünsterland Stadtlohn
Germany Johanniter-Krankenhaus Genthin-Stendal Stendal
Germany Robert-Bosch-Krankenhaus Stuttgart
Germany Krankenhaus der Barmherzigen Brüder Trier Trier
Germany Klinikum Landkreis Tuttlingen Tuttlingen
Germany Universitätsklinikum Ulm Ulm
Germany Aller-Weser-Klinik - Krankenhaus Verden Verden
Germany Schwarzwald-Baar Klinikum Villingen-Schwenningen
Germany Helios Klinikum Warburg GmbH Warburg
Germany Sophien- und Hufeland-Klinikum Weimar
Germany Rems-Murr-Klinikum Winnenden Winnenden
Germany Helios Universitätsklinikum Wuppertal Wuppertal
Germany Universitätsklinikum Würzburg Würzburg
Germany Heinrich-Braun-Klinikum Zwickau

Sponsors (2)

Lead Sponsor Collaborator
Helios Health Institute GmbH Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time from randomisation to the occurrence of all-cause death Time from randomisation to the occurrence of all-cause death Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Time from randomisation to death from cardiac causes Time from randomisation to death from cardiac causes Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Time from randomisation to sudden cardiac death Time from randomisation to sudden cardiac death Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Time from randomisation to life-threatening arrhythmias Time from randomisation to life-threatening arrhythmias Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Time from randomisation to first composite of Major Adverse Cardiac Event (MACE) Time from randomisation to first composite of Major Adverse Cardiac Event (MACE) Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Time from randomisation to first hospitalisation for cardiovascular reasons Time from randomisation to first hospitalisation for cardiovascular reasons Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Nights spent in hospital for cardiovascular reasons per year of follow-up 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 cardiovascular reasons 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. Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Number of hospital readmissions for cardiovascular reasons after randomisation Number of hospital readmissions for cardiovascular reasons after randomisation Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Changes in quality of life (EQ-5D) comparing inclusion/enrolment with 12 and 24 months Quality of life will be measured using the European Quality of life 5 Dimension (EQ5D) questionnaire including its visual-analogue scale (Scores range from 0-100 where 0 is the worst score). at baseline, 12 and 24 months after randomisation
Secondary Total cost of treatment as compound endpoint of MACEs, number of hospital days for cardiovascular reasons and ambulatory visits for cardiovascular reasons otal cost of treatment as compound endpoint of MACEs, number of hospital days for cardiovascular reasons and ambulatory visits for cardiovascular reasons Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
See also
  Status Clinical Trial Phase
Completed NCT03597646 - The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure N/A
Terminated NCT04065997 - Apogee International
Withdrawn NCT03675113 - Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure N/A
Completed NCT02916160 - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study Phase 4
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Completed NCT02268500 - VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT) Phase 4
Completed NCT02247245 - The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. N/A
Completed NCT01919918 - Muscle Afferent Feedback Effects in Patients With Heart Failure Phase 1
Terminated NCT01906957 - Cognition and Exercise Training N/A
Not yet recruiting NCT01669395 - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial N/A
Completed NCT00984529 - Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia N/A
Recruiting NCT00863421 - Sleep Disordered Breathing in Patients With Chronic Heart Failure N/A
Completed NCT02840565 - Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 Phase 1
Completed NCT02441218 - Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study Phase 3
Completed NCT00149409 - Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure Phase 2/Phase 3
Terminated NCT05532046 - A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) Phase 1
Recruiting NCT04984928 - Readmission Risk of Patients With Heart Failure.
Completed NCT02814097 - A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction Phase 2
Active, not recruiting NCT05560737 - ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I