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Budapest Upgrade CRT Study (Version 009-4.1)

Primary Purpose

Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CRT-D
Sponsored by
Semmelweis University Heart and Vascular Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiomyopathy focused on measuring cardiac resynchronization therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female patients over the age of 18 (expected survival time: over 1 year)
  • Patients with ischemic or non-ischemic cardiomyopathy;
  • Those implanted with a single or dual chamber ICD or implanted with a single or dual chamber pacemaker at least 6 months before inclusion;
  • Elective generator replacement or upgrade from pacemaker-only to ICD therapy may be indicated at the time of enrollment, but are not required;
  • Right ventricular pacing 20-100% in at least the last 90 days before enrollment (with an optimal AV interval based on the physician's discretion to avoid unnecessary right ventricular stimulation);
  • Symptomatic heart failure for at least 3 months before inclusion;
  • NYHA functional class II or III, or IV a;
  • Left ventricular ejection fraction measured by echocardiography ≤ 35%;
  • Paced QRS complex ≥ 150 ms;
  • Optimal heart failure medical therapy;
  • Informed consent obtained.

Exclusion Criteria:

  • Intrinsic QRS with LBBB morphology (measured at VVI 40 bpm setting as per protocol);
  • CABG or PCI in the past 3 months;
  • Acute myocardial infarction in the past 3 months;
  • Unstable angina;
  • Planned coronary revascularization (PCI or CABG);
  • Planned cardiac transplantation;
  • Acute myocarditis;
  • Infiltrative myocardial disease;
  • Hypertrophic cardiomyopathy;
  • Severe primary mitral and aortic valve stenosis or regurgitation;
  • Women who are pregnant or plan to become pregnant or breastfeeding;
  • Subjects who are unable or unwilling to cooperate with the study protocol;
  • Tricuspid valve prosthesis;
  • Any serious disease likely to interfere with the conduct of the study;
  • Participation in other clinical trial;
  • Patients geographically not stable or unavailable for follow-up;
  • Chronic, severe renal dysfunction (creatinine value > 200 μmol/l);
  • Severe RV dilatation (RV basal diameter >50mm);
  • Severe tricuspid insufficiency.

Sites / Locations

  • Hannover Medical School
  • Herzzentrum Leipzig GmbH
  • Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged
  • Institute of Cardiology University of Debrecen
  • Hungarian Institute of Cardiology
  • Semmelweis University Heart and Vascular Center
  • Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center
  • University of Pécs Medical School, Heart Institute
  • Barzilai Medical Center
  • Kaplan Medical Center
  • Central Clinical Hospital of Silesia, Department of Electrocardiology
  • Department of Interventional Cardiology, Medical University of Lodz,
  • Medical Center Tronik
  • Medical University of Warsaw
  • Clinical Center of Serbia
  • SK-01 National Institute for Cardiovascular Diseases
  • University Medical Center Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CRT-D

Only ICD

Arm Description

Patients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT.

In the ICD arm, choosing single or dual chamber device is based upon the investigator's discretion. Subjects meeting the inclusion criteria (and if exclusion criteria are not present) patients will be randomized to CRT-D upgrade or ICD only (either continued ICD therapy in patients currently implanted with a defibrillator or implantation of a defibrillator in eligible patients who are currently implanted with pacemaker-only).

Outcomes

Primary Outcome Measures

A composite clinical and echocardiographic end point comprising the first occurrence of a non-fatal heart failure event, all-cause mortality, or < 15% reduction in echocardiography determined LVESV from baseline to 12-month.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2014
Last Updated
June 2, 2023
Sponsor
Semmelweis University Heart and Vascular Center
Collaborators
University of Rochester, Sheba Medical Center, Pharmahungary Group
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1. Study Identification

Unique Protocol Identification Number
NCT02270840
Brief Title
Budapest Upgrade CRT Study (Version 009-4.1)
Official Title
Effect of Biventricular Upgrade on Left Ventricular Reverse Remodeling and Clinical Outcomes in Patient With Left Ventricular Dysfunction and Intermittent or Permanent Apical/Septal Right Ventricular Pacing (Budapest CRT Upgrade Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
August 2022 (Actual)
Study Completion Date
August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University Heart and Vascular Center
Collaborators
University of Rochester, Sheba Medical Center, Pharmahungary Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes in patient in left ventricular dysfunction and intermittent or permanent apical/septal right ventricular pacing (Budapest CRT upgrade study)
Detailed Description
The aim of this study is to investigate the effect of upgrade to a CRT-D device on clinical and echocardiographic response at 12-month in patients with left ventricular dysfunction (LVEF ≤35%), symptomatic heart failure (NYHA II, III, IV-a), and intermittent or permanent right ventricular pacing with paced QRS complex ≥ 150 ms compared to continued therapy with a single or dual chamber pacemaker (PM) or ICD. Prospective, post-market, international multicenter randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy
Keywords
cardiac resynchronization therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-D
Arm Type
Active Comparator
Arm Description
Patients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT.
Arm Title
Only ICD
Arm Type
No Intervention
Arm Description
In the ICD arm, choosing single or dual chamber device is based upon the investigator's discretion. Subjects meeting the inclusion criteria (and if exclusion criteria are not present) patients will be randomized to CRT-D upgrade or ICD only (either continued ICD therapy in patients currently implanted with a defibrillator or implantation of a defibrillator in eligible patients who are currently implanted with pacemaker-only).
Intervention Type
Device
Intervention Name(s)
CRT-D
Intervention Description
Biventricular upgrade. Subjects meeting the inclusion criteria (and if exclusion criteria are not present) patients will be randomized to CRT-D upgrade or ICD only (either continued ICD therapy in patients currently implanted with a defibrillator or implantation of a defibrillator in eligible patients who are currently implanted with pacemaker-only).
Primary Outcome Measure Information:
Title
A composite clinical and echocardiographic end point comprising the first occurrence of a non-fatal heart failure event, all-cause mortality, or < 15% reduction in echocardiography determined LVESV from baseline to 12-month.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients over the age of 18 (expected survival time: over 1 year) Patients with ischemic or non-ischemic cardiomyopathy; Those implanted with a single or dual chamber ICD or implanted with a single or dual chamber pacemaker at least 6 months before inclusion; Elective generator replacement or upgrade from pacemaker-only to ICD therapy may be indicated at the time of enrollment, but are not required; Right ventricular pacing 20-100% in at least the last 90 days before enrollment (with an optimal AV interval based on the physician's discretion to avoid unnecessary right ventricular stimulation); Symptomatic heart failure for at least 3 months before inclusion; NYHA functional class II or III, or IV a; Left ventricular ejection fraction measured by echocardiography ≤ 35%; Paced QRS complex ≥ 150 ms; Optimal heart failure medical therapy; Informed consent obtained. Exclusion Criteria: Intrinsic QRS with LBBB morphology (measured at VVI 40 bpm setting as per protocol); CABG or PCI in the past 3 months; Acute myocardial infarction in the past 3 months; Unstable angina; Planned coronary revascularization (PCI or CABG); Planned cardiac transplantation; Acute myocarditis; Infiltrative myocardial disease; Hypertrophic cardiomyopathy; Severe primary mitral and aortic valve stenosis or regurgitation; Women who are pregnant or plan to become pregnant or breastfeeding; Subjects who are unable or unwilling to cooperate with the study protocol; Tricuspid valve prosthesis; Any serious disease likely to interfere with the conduct of the study; Participation in other clinical trial; Patients geographically not stable or unavailable for follow-up; Chronic, severe renal dysfunction (creatinine value > 200 μmol/l); Severe RV dilatation (RV basal diameter >50mm); Severe tricuspid insufficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Kutyifa, MD
Organizational Affiliation
University of Rochester Medical Center, Rochester, NY, USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ilan Goldenberg, Prof. MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Béla Merkely, Prof. MD
Organizational Affiliation
Semmelweis University Hearth and Vascular Center, Budapest, Hungary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annamaria Kosztin, MD
Organizational Affiliation
Semmelweis University Hearth and Vascular Center, Budapest, Hungary
Official's Role
Study Director
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Institute of Cardiology University of Debrecen
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Hungarian Institute of Cardiology
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Semmelweis University Heart and Vascular Center
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
University of Pécs Medical School, Heart Institute
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Central Clinical Hospital of Silesia, Department of Electrocardiology
City
Katowice
ZIP/Postal Code
40-629
Country
Poland
Facility Name
Department of Interventional Cardiology, Medical University of Lodz,
City
Lodz
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Medical Center Tronik
City
Lodz
ZIP/Postal Code
90-553
Country
Poland
Facility Name
Medical University of Warsaw
City
Warszawa
ZIP/Postal Code
02-091
Country
Poland
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
SK-01 National Institute for Cardiovascular Diseases
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Facility Name
University Medical Center Ljubljana
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35791276
Citation
Merkely B, Geller L, Zima E, Osztheimer I, Molnar L, Foldesi C, Duray G, Wranicz JK, Nemeth M, Goscinska-Bis K, Hatala R, Saghy L, Veres B, Schwertner WR, Fabian A, Fodor E, Goldenberg I, Kutyifa V, Kovacs A, Kosztin A. Baseline clinical characteristics of heart failure patients with reduced ejection fraction enrolled in the BUDAPEST-CRT Upgrade trial. Eur J Heart Fail. 2022 Sep;24(9):1652-1661. doi: 10.1002/ejhf.2609. Epub 2022 Jul 22.
Results Reference
derived
PubMed Identifier
28339581
Citation
Merkely B, Kosztin A, Roka A, Geller L, Zima E, Kovacs A, Boros AM, Klein H, Wranicz JK, Hindricks G, Clemens M, Duray GZ, Moss AJ, Goldenberg I, Kutyifa V. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial. Europace. 2017 Sep 1;19(9):1549-1555. doi: 10.1093/europace/euw193.
Results Reference
derived
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28339581/
Description
Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial

Learn more about this trial

Budapest Upgrade CRT Study (Version 009-4.1)

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