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Budapest Upgrade CRT Study (Version 009-4.1)

Sponsor
Semmelweis University Heart and Vascular Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02270840
Collaborator
University of Rochester (Other), Sheba Medical Center (Other), Pharmahungary Group (Industry)
360
Enrollment
17
Locations
93
Duration (Months)
21.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Device: CRT-D

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 Design

Study Type:
Observational
Actual Enrollment :
360 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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 Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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).
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).

Outcome Measures

Primary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hannover Medical School Hannover Germany 30625
2 Herzzentrum Leipzig GmbH Leipzig Germany 04289
3 Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged Szeged Csongrád Hungary 6725
4 Institute of Cardiology University of Debrecen Debrecen Hajdú-Bihar Hungary 4032
5 Hungarian Institute of Cardiology Budapest Hungary 1096
6 Semmelweis University Heart and Vascular Center Budapest Hungary 1122
7 Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center Budapest Hungary 1134
8 University of Pécs Medical School, Heart Institute Pécs Hungary 7624
9 Barzilai Medical Center Ashkelon Israel 78278
10 Kaplan Medical Center Rehovot Israel 76100
11 Central Clinical Hospital of Silesia, Department of Electrocardiology Katowice Poland 40-629
12 Department of Interventional Cardiology, Medical University of Lodz, Lodz Poland 90-549
13 Medical Center Tronik Lodz Poland 90-553
14 Medical University of Warsaw Warszawa Poland 02-091
15 Clinical Center of Serbia Belgrade Serbia 11000
16 SK-01 National Institute for Cardiovascular Diseases Bratislava Slovakia 833 48
17 University Medical Center Ljubljana Ljubljana Slovenia

Sponsors and Collaborators

  • Semmelweis University Heart and Vascular Center
  • University of Rochester
  • Sheba Medical Center
  • 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 Tel-Hashomer, Israel
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier:
NCT02270840
Other Study ID Numbers:
  • Budapest Upgrade CRT 009-4.1
First Posted:
Oct 21, 2014
Last Update Posted:
Jan 10, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Semmelweis University Heart and Vascular Center
cardiac resynchronization therapy
Additional relevant MeSH terms:
Cardiomyopathies

Study Results

No Results Posted as of Jan 10, 2022