Clinical trial NCT02270840: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathy
Keywords: cardiac resynchronization therapy
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: University of Rochester
name: Sheba Medical Center
name: Pharmahungary Group
First posted: 2014-10-21
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Szeged
country: Hungary
facility: Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged
state: Csongrád
city: Debrecen
country: Hungary
facility: Institute of Cardiology University of Debrecen
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Hungarian Institute of Cardiology
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
city: Budapest
country: Hungary
facility: Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center
city: Pécs
country: Hungary
facility: University of Pécs Medical School, Heart Institute
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Katowice
country: Poland
facility: Central Clinical Hospital of Silesia, Department of Electrocardiology
city: Lodz
country: Poland
facility: Department of Interventional Cardiology, Medical University of Lodz,
city: Lodz
country: Poland
facility: Medical Center Tronik
city: Warszawa
country: Poland
facility: Medical University of Warsaw
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Bratislava
country: Slovakia
facility: SK-01 National Institute for Cardiovascular Diseases
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
affiliation: University of Rochester Medical Center, Rochester, NY, USA
name: Valentina Kutyifa, MD
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Ilan Goldenberg, Prof. MD
role: STUDY_DIRECTOR
affiliation: Semmelweis University Hearth and Vascular Center, Budapest, Hungary
name: Béla Merkely, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University Hearth and Vascular Center, Budapest, Hungary
name: Annamaria Kosztin, MD
role: STUDY_DIRECTOR
References:
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.
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.