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

Primary Purpose

Chronic Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CRT-P implantation
CRT-D implantation
Sponsored by
Helios Health Institute GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRT-P group

CRT-D group

Arm Description

Intervention: CRT-P implantation

Intervention: CRT-D implantation

Outcomes

Primary Outcome Measures

Time from randomisation to the occurrence of all-cause death
Time from randomisation to the occurrence of all-cause death

Secondary Outcome Measures

Time from randomisation to death from cardiac causes
Time from randomisation to death from cardiac causes
Time from randomisation to sudden cardiac death
Time from randomisation to sudden cardiac death
Time from randomisation to life-threatening arrhythmias
Time from randomisation to life-threatening arrhythmias
Time from randomisation to first composite of Major Adverse Cardiac Event (MACE)
Time from randomisation to first composite of Major Adverse Cardiac Event (MACE)
Time from randomisation to first hospitalisation for cardiovascular reasons
Time from randomisation to first hospitalisation for cardiovascular reasons
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.
Number of hospital readmissions for cardiovascular reasons after randomisation
Number of hospital readmissions for cardiovascular reasons after randomisation
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).
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

Full Information

First Posted
March 15, 2018
Last Updated
August 1, 2023
Sponsor
Helios Health Institute GmbH
Collaborators
Heart Center Leipzig - University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03494933
Brief Title
Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure
Acronym
RESET-CRT
Official Title
Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure - An Investigator-initiated, Event-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial Without Investigational Medical Products (Proof of Strategy Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
End of the Funding period, no further funding to complete the trial could be saved
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
February 21, 2023 (Actual)
Study Completion Date
February 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helios Health Institute GmbH
Collaborators
Heart Center Leipzig - University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
959 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-P group
Arm Type
Experimental
Arm Description
Intervention: CRT-P implantation
Arm Title
CRT-D group
Arm Type
Active Comparator
Arm Description
Intervention: CRT-D implantation
Intervention Type
Procedure
Intervention Name(s)
CRT-P implantation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CRT-D implantation
Intervention Description
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 Measure Information:
Title
Time from randomisation to the occurrence of all-cause death
Description
Time from randomisation to the occurrence of all-cause death
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Secondary Outcome Measure Information:
Title
Time from randomisation to death from cardiac causes
Description
Time from randomisation to death from cardiac causes
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Title
Time from randomisation to sudden cardiac death
Description
Time from randomisation to sudden cardiac death
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Title
Time from randomisation to life-threatening arrhythmias
Description
Time from randomisation to life-threatening arrhythmias
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Title
Time from randomisation to first composite of Major Adverse Cardiac Event (MACE)
Description
Time from randomisation to first composite of Major Adverse Cardiac Event (MACE)
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Title
Time from randomisation to first hospitalisation for cardiovascular reasons
Description
Time from randomisation to first hospitalisation for cardiovascular reasons
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Title
Nights spent in hospital for cardiovascular reasons per year of follow-up
Description
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.
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Title
Number of hospital readmissions for cardiovascular reasons after randomisation
Description
Number of hospital readmissions for cardiovascular reasons after randomisation
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)
Title
Changes in quality of life (EQ-5D) comparing inclusion/enrolment with 12 and 24 months
Description
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).
Time Frame
at baseline, 12 and 24 months after randomisation
Title
Total cost of treatment as compound endpoint of MACEs, number of hospital days for cardiovascular reasons and ambulatory visits for cardiovascular reasons
Description
otal cost of treatment as compound endpoint of MACEs, number of hospital days for cardiovascular reasons and ambulatory visits for cardiovascular reasons
Time Frame
Randomization to end of study (event-driven, expected about 9 to 20 months after last patient in)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Hindricks, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinikum Aue
City
Aue
ZIP/Postal Code
08280
Country
Germany
Facility Name
Zentralklinik Bad Berka
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Universitäts-Herzzentrum
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Marienhaus Klinikum im Kreis Ahrweiler
City
Bad Neuenahr-Ahrweiler
ZIP/Postal Code
53474
Country
Germany
Facility Name
RHÖN-KLINIKUM Campus Bad Neustadt
City
Bad Neustadt a.d. Saale
ZIP/Postal Code
97616
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Segeberger Kliniken
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Maria-Hilf-Krankenhaus Bergheim
City
Bergheim
ZIP/Postal Code
50126
Country
Germany
Facility Name
Sana Klinikum Lichtenberg
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
ZIP/Postal Code
12683
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Jüdisches Krankenhaus Berlin
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Vivantes Klinikum Spandau
City
Berlin
ZIP/Postal Code
13585
Country
Germany
Facility Name
Helios Klinikum Emil von Behring
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Immanuel Klinikum Bernau - Herzzentrum Brandenburg
City
Bernau bei Berlin
ZIP/Postal Code
16321
Country
Germany
Facility Name
Klinikum Bielefeld
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Augusta Kliniken Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Knappschaftskrankenhaus Bottrop
City
Bottrop
ZIP/Postal Code
46242
Country
Germany
Facility Name
REGIOMED-KLINIKEN Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Carl-Thiem-Klinikum
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Helios Amper-Klinikum Dachau
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Klinikum Lippe Detmold
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
St.-Johannes-Hospital Dortmund
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Herz Zentrum Westfalen - Knappschaftskrankenhaus Dortmund
City
Dortmund
ZIP/Postal Code
44309
Country
Germany
Facility Name
Praxisklinik Herz und Gefäße
City
Dresden
ZIP/Postal Code
01099
Country
Germany
Facility Name
Herzzentrum Dresden Universitätsklinik
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Hermann-Josef-Krankenhaus Erkelenz
City
Erkelenz
ZIP/Postal Code
41812
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Contilia Herz- und Gefäßzentrum
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Ev.-Luth. Diakonissenanstalt zu Flensburg
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Kreiskrankenhaus Freiberg
City
Freiberg
ZIP/Postal Code
09599
Country
Germany
Facility Name
Klinikum Fulda
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
UKGM - Universitätsklinikum Gießen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Asklepios Harzklinik Goslar
City
Goslar
ZIP/Postal Code
38642
Country
Germany
Facility Name
Helios Klinikum Gotha
City
Gotha
ZIP/Postal Code
99867
Country
Germany
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37099
Country
Germany
Facility Name
Klinikum Gütersloh gGmbH
City
Gütersloh
ZIP/Postal Code
33332
Country
Germany
Facility Name
Evangelisches Krankenhaus Hagen-Haspe
City
Hagen
ZIP/Postal Code
58135
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Dölau
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf (UKE)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Asklepios Kliniken Hamburg GmbH
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Albertinen Herz- und Gefäßzentrum - Albertinen Krankenhaus
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
St. Marien-Hospital Hamm
City
Hamm
ZIP/Postal Code
59071
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Helios St. Marienberg Klinik Helmstedt
City
Helmstedt
ZIP/Postal Code
38350
Country
Germany
Facility Name
Oberhavel Kliniken
City
Hennigsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Helios Klinikum Hildesheim
City
Hildesheim
ZIP/Postal Code
31135
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinikum Ingolstadt
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
B. Braun Ambulantes Herzzentrum Kassel
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Städtisches Krankenhaus Kiel
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Katholisches Klinikum Koblenz - Montabaur
City
Koblenz
ZIP/Postal Code
56073
Country
Germany
Facility Name
Helios Klinikum Krefeld
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
St. Vinzenz-Hospital
City
Köln
ZIP/Postal Code
50733
Country
Germany
Facility Name
Herzzentrum Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Krankenhaus Porz am Rhein
City
Köln
ZIP/Postal Code
51149
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Klinikum Leverkusen
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Cardio Centrum Ludwigburg
City
Ludwigsburg
ZIP/Postal Code
71634
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum Lüdenscheid
City
Lüdenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
St.-Marien-Hospital Lünen
City
Lünen
ZIP/Postal Code
44534
Country
Germany
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Ev. Krankenhaus Bethesda Mönchengladbach
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Kliniken Maria Hilf
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Städtische Kliniken Mönchengladbach - Elisabeth-Krankenhaus Rheydt
City
Mönchengladbach
ZIP/Postal Code
41239
Country
Germany
Facility Name
Klinik Augustinum
City
München
ZIP/Postal Code
81375
Country
Germany
Facility Name
LMU Klinikum
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Technische Universität München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
München Klinik Neuperlach
City
München
ZIP/Postal Code
81737
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Havelland Kliniken
City
Nauen
ZIP/Postal Code
14641
Country
Germany
Facility Name
Marienhaus Klinikum St. Elisabeth Neuwied
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Klinikum Nürnberg Süd
City
Nürnberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
St. Vincenz-Krankenhaus
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Helios Vogtland-Klinikum Plauen
City
Plauen
ZIP/Postal Code
08529
Country
Germany
Facility Name
Harzklinikum Dorothea Christiane Erxleben Klinikum Quedlinburg
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Elblandklinikum Riesa
City
Riesa
ZIP/Postal Code
01589
Country
Germany
Facility Name
Universitätsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Asklepios Klinikum Uckermark
City
Schwedt/Oder
ZIP/Postal Code
16303
Country
Germany
Facility Name
Helios Kliniken Schwerin
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Facility Name
Helios Klinikum Siegburg
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Marien Kliniken
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Diakonie Klinikum Jung-Stilling
City
Siegen
ZIP/Postal Code
57074
Country
Germany
Facility Name
Krankenhaus Maria-Hilf Stadtlohn Klinikum Westmünsterland
City
Stadtlohn
ZIP/Postal Code
48703
Country
Germany
Facility Name
Johanniter-Krankenhaus Genthin-Stendal
City
Stendal
ZIP/Postal Code
39576
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder Trier
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Klinikum Landkreis Tuttlingen
City
Tuttlingen
ZIP/Postal Code
78532
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Aller-Weser-Klinik - Krankenhaus Verden
City
Verden
ZIP/Postal Code
27283
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Helios Klinikum Warburg GmbH
City
Warburg
ZIP/Postal Code
34414
Country
Germany
Facility Name
Sophien- und Hufeland-Klinikum
City
Weimar
ZIP/Postal Code
99425
Country
Germany
Facility Name
Rems-Murr-Klinikum Winnenden
City
Winnenden
ZIP/Postal Code
71364
Country
Germany
Facility Name
Helios Universitätsklinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Heinrich-Braun-Klinikum
City
Zwickau
ZIP/Postal Code
08060
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33992569
Citation
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.
Results Reference
derived

Learn more about this trial

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

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