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

NCT03494933 | Terminated DMC

• 1 other identifier: HRC048864
• Study Type: interventional
• Target: 959
• Locations: 1 country
• Sites: 113

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

• Time from randomisation to sudden cardiac death

  Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)

• Time from randomisation to life-threatening arrhythmias

  Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)

• 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)

• 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)

Study Arms (2)

CRT-P group

EXPERIMENTAL

Intervention: CRT-P implantation

Procedure: CRT-P implantation

CRT-D group

ACTIVE COMPARATOR

Intervention: CRT-D implantation

Procedure: CRT-D implantation

Interventions

CRT-P implantation PROCEDURE

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-P group

CRT-D implantation PROCEDURE

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.

CRT-D group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helios Health Institute GmbH: lead
• Heart Center Leipzig - University Hospital: collaborator

Study Sites (113)

Helios Klinikum Aue

Aue, 08280, Germany

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Universitäts-Herzzentrum

Bad Krozingen, 79189, Germany

Location

Marienhaus Klinikum im Kreis Ahrweiler

Bad Neuenahr-Ahrweiler, 53474, Germany

Location

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt A.d. Saale, 97616, Germany

Location

Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Location

Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Maria-Hilf-Krankenhaus Bergheim

Bergheim, 50126, Germany

Location

Sana Klinikum Lichtenberg

Berlin, 10365, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Jüdisches Krankenhaus Berlin

Berlin, 13347, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Vivantes Klinikum Spandau

Berlin, 13585, Germany

Location

Helios Klinikum Emil von Behring

Berlin, 14165, Germany

Location

Immanuel Klinikum Bernau - Herzzentrum Brandenburg

Bernau bei Berlin, 16321, Germany

Location

Klinikum Bielefeld

Bielefeld, 33604, Germany

Location

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, 44789, Germany

Location

Augusta Kliniken Bochum

Bochum, 44791, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Knappschaftskrankenhaus Bottrop

Bottrop, 46242, Germany

Location

REGIOMED-KLINIKEN Klinikum Coburg

Coburg, 96450, Germany

Location

St. Vinzenz-Hospital

Cologne, 50733, Germany

Location

Herzzentrum Uniklinik Köln

Cologne, 50937, Germany

Location

Krankenhaus Porz am Rhein

Cologne, 51149, Germany

Location

Carl-Thiem-Klinikum

Cottbus, 03048, Germany

Location

Helios Amper-Klinikum Dachau

Dachau, 85221, Germany

Location

Klinikum Lippe Detmold

Detmold, 32756, Germany

Location

St.-Johannes-Hospital Dortmund

Dortmund, 44137, Germany

Location

Herz Zentrum Westfalen - Knappschaftskrankenhaus Dortmund

Dortmund, 44309, Germany

Location

Praxisklinik Herz und Gefäße

Dresden, 01099, Germany

Location

Herzzentrum Dresden Universitätsklinik

Dresden, 01307, Germany

Location

Helios Klinikum Erfurt

Erfurt, 99089, Germany

Location

Hermann-Josef-Krankenhaus Erkelenz

Erkelenz, 41812, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Contilia Herz- und Gefäßzentrum

Essen, 45138, Germany

Location

Ev.-Luth. Diakonissenanstalt zu Flensburg

Flensburg, 24939, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Kreiskrankenhaus Freiberg

Freiberg, 09599, Germany

Location

Klinikum Fulda

Fulda, 36043, Germany

Location

UKGM - Universitätsklinikum Gießen

Giessen, 35392, Germany

Location

Asklepios Harzklinik Goslar

Goslar, 38642, Germany

Location

Helios Klinikum Gotha

Gotha, 99867, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37099, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

Klinikum Gütersloh gGmbH

Gütersloh, 33332, Germany

Location

Evangelisches Krankenhaus Hagen-Haspe

Hagen, 58135, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau

Halle, 06120, Germany

Location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

Location

Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg

Hamburg, 21075, Germany

Location

Asklepios Kliniken Hamburg GmbH

Hamburg, 21075, Germany

Location

Albertinen Herz- und Gefäßzentrum - Albertinen Krankenhaus

Hamburg, 22457, Germany

Location

St. Marien-Hospital Hamm

Hamm, 59071, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Helios St. Marienberg Klinik Helmstedt

Helmstedt, 38350, Germany

Location

Oberhavel Kliniken

Hennigsdorf, 16761, Germany

Location

Helios Klinikum Hildesheim

Hildesheim, 31135, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Klinikum Ingolstadt

Ingolstadt, 85049, Germany

Location

Universitätsklinikum Jena

Jena, 07743, Germany

Location

Westpfalz-Klinikum GmbH

Kaiserslautern, 67655, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

B. Braun Ambulantes Herzzentrum Kassel

Kassel, 34121, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Städtisches Krankenhaus Kiel

Kiel, 24116, Germany

Location

Katholisches Klinikum Koblenz - Montabaur

Koblenz, 56073, Germany

Location

Helios Klinikum Krefeld

Krefeld, 47805, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Klinikum Leverkusen

Leverkusen, 51375, Germany

Location

Cardio Centrum Ludwigburg

Ludwigsburg, 71634, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, 58515, Germany

Location

St.-Marien-Hospital Lünen

Lünen, 44534, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

Location

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

Location

Ev. Krankenhaus Bethesda Mönchengladbach

Mönchengladbach, 41061, Germany

Location

Kliniken Maria Hilf

Mönchengladbach, 41063, Germany

Location

Städtische Kliniken Mönchengladbach - Elisabeth-Krankenhaus Rheydt

Mönchengladbach, 41239, Germany

Location

Klinik Augustinum

München, 81375, Germany

Location

LMU Klinikum

München, 81377, Germany

Location

Technische Universität München

München, 81675, Germany

Location

München Klinik Neuperlach

München, 81737, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Havelland Kliniken

Nauen, 14641, Germany

Location

Marienhaus Klinikum St. Elisabeth Neuwied

Neuwied, 56564, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

Location

St. Vincenz-Krankenhaus

Paderborn, 33098, Germany

Location

Helios Vogtland-Klinikum Plauen

Plauen, 08529, Germany

Location

Harzklinikum Dorothea Christiane Erxleben Klinikum Quedlinburg

Quedlinburg, 06484, Germany

Location

Elblandklinikum Riesa

Riesa, 01589, Germany

Location

Universitätsmedizin Rostock

Rostock, 18057, Germany

Location

Asklepios Klinikum Uckermark

Schwedt, 16303, Germany

Location

Helios Kliniken Schwerin

Schwerin, 19049, Germany

Location

Helios Klinikum Siegburg

Siegburg, 53721, Germany

Location

Marien Kliniken

Siegen, 57072, Germany

Location

Diakonie Klinikum Jung-Stilling

Siegen, 57074, Germany

Location

Krankenhaus Maria-Hilf Stadtlohn Klinikum Westmünsterland

Stadtlohn, 48703, Germany

Location

Johanniter-Krankenhaus Genthin-Stendal

Stendal, 39576, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292, Germany

Location

Klinikum Landkreis Tuttlingen

Tuttlingen, 78532, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Aller-Weser-Klinik - Krankenhaus Verden

Verden an der Aller, 27283, Germany

Location

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, 78052, Germany

Location

Helios Klinikum Warburg GmbH

Warburg, 34414, Germany

Location

Sophien- und Hufeland-Klinikum

Weimar, 99425, Germany

Location

Rems-Murr-Klinikum Winnenden

Winnenden, 71364, Germany

Location

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Heinrich-Braun-Klinikum

Zwickau, 08060, Germany

Location

Related Publications (1)

• Chatterjee NA, Poole JE. Cardiac Resynchronization Therapy in Nonischemic Cardiomyopathy: To D or P? JACC Heart Fail. 2021 Jun;9(6):450-452. doi: 10.1016/j.jchf.2021.04.001. Epub 2021 May 12. No abstract available.

  PMID: 33992569 DERIVED

Study Officials

• Gerhard Hindricks, MD

  Heart Center Leipzig - University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 11, 2018
• Study Start: September 1, 2018
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: August 3, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (113)