Budapest Upgrade CRT Study (Version 009-4.1)

June 2, 2023 updated by: Semmelweis University Heart and Vascular Center

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig GmbH
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis University Heart and Vascular Center
      • Budapest, Hungary, 1096
        • Hungarian Institute of Cardiology
      • Budapest, Hungary, 1134
        • Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center
      • Pécs, Hungary, 7624
        • University of Pécs Medical School, Heart Institute
    • Csongrád
      • Szeged, Csongrád, Hungary, 6725
        • Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Institute of Cardiology University of Debrecen
  • Israel
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
  • Poland
      • Katowice, Poland, 40-629
        • Central Clinical Hospital of Silesia, Department of Electrocardiology
      • Lodz, Poland, 90-549
        • Department of Interventional Cardiology, Medical University of Lodz,
      • Lodz, Poland, 90-553
        • Medical Center Tronik
      • Warszawa, Poland, 02-091
        • Medical University of Warsaw
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
  • Slovakia
      • Bratislava, Slovakia, 833 48
        • SK-01 National Institute for Cardiovascular Diseases
  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Altogether 360 subjects will be enrolled at the European and Israeli study sites, randomized in the rate of 3:2 (CRT-D:ICD groups).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CRT-D
Patients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT.
Device: CRT-D
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).
No Intervention: Only ICD

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Collaborators

Sheba Medical Center
University of Rochester
Pharmahungary Group

Investigators

  • Study Director: Valentina Kutyifa, MD, University of Rochester Medical Center, Rochester, NY, USA
  • Study Director: Ilan Goldenberg, Prof. MD, Sheba Medical Center
  • Principal Investigator: Béla Merkely, Prof. MD, Semmelweis University Hearth and Vascular Center, Budapest, Hungary
  • Study Director: Annamaria Kosztin, MD, Semmelweis University Hearth and Vascular Center, Budapest, Hungary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimated)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Budapest Upgrade CRT 009-4.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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