Budapest Upgrade CRT Study (Version 009-4.1)

NCT02270840 | Completed DMC

• 1 other identifier: Budapest Upgrade CRT 009-4.1
• Study Type: interventional
• Target: 360
• Locations: 6 countries
• Sites: 16

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)

Conditions

Cardiomyopathy

Keywords

cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (2)

CRT-D

ACTIVE COMPARATOR

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

Device: CRT-D

Only ICD

NO INTERVENTION

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).

Interventions

CRT-D DEVICE

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).

CRT-D

Eligibility Criteria

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

You may qualify if:

• Male or female patients over the age of 18 (expected survival time: over 1 year)
• Patients with ischemic or non-ischemic cardiomyopathy;
• 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);
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead
• University of Rochester: collaborator
• Sheba Medical Center: collaborator
• Pharmahungary Group: collaborator

Study Sites (17)

Hannover Medical School

Hanover, 30625, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged

Szeged, Csongrád megye, 6725, Hungary

Location

Institute of Cardiology University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Hungarian Institute of Cardiology

Budapest, 1096, Hungary

Location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center

Budapest, 1134, Hungary

Location

University of Pécs Medical School, Heart Institute

Pécs, 7624, Hungary

Location

Barzilai Medical Center

Ashkelon, 78278, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Central Clinical Hospital of Silesia, Department of Electrocardiology

Katowice, 40-629, Poland

Location

Department of Interventional Cardiology, Medical University of Lodz,

Lodz, 90-549, Poland

Location

Medical Center Tronik

Lodz, 90-553, Poland

Location

Medical University of Warsaw

Warsaw, 02-091, Poland

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

SK-01 National Institute for Cardiovascular Diseases

Bratislava, 833 48, Slovakia

Location

University Medical Center Ljubljana

Ljubljana, Slovenia

Location

Related Publications (3)

• Merkel E, Hatala R, Szigeti M, Schwertner W, Lakatos B, Behon A, Goscinska-Bis K, Milasinovic G, Papp R, Ruppert M, Saghy L, Clemens M, Solomon SD, Kutyifa V, Kovacs A, Kosztin A, Merkely B. Upgrading Right Ventricular Pacing to Cardiac Resynchronization in HFrEF Patients Improves Symptoms and Functional Outcomes. JACC Heart Fail. 2025 Feb;13(2):265-273. doi: 10.1016/j.jchf.2024.09.011. Epub 2024 Nov 27.

  PMID: 39614838 DERIVED

• 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.

  PMID: 35791276 DERIVED

• 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.

  PMID: 28339581 DERIVED

Related Links

• Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Valentina Kutyifa, MD

  University of Rochester Medical Center, Rochester, NY, USA

  STUDY DIRECTOR

• Ilan Goldenberg, Prof. MD

  Sheba Medical Center

  STUDY DIRECTOR

• Béla Merkely, Prof. MD

  Semmelweis University Hearth and Vascular Center, Budapest, Hungary

  PRINCIPAL INVESTIGATOR

• Annamaria Kosztin, MD

  Semmelweis University Hearth and Vascular Center, Budapest, Hungary

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

HU (6); SL (1); DE (2); PL (4); SE (1); IL (2)