Budapest Upgrade CRT Study (Version 009-4.1)

Not Applicable

Completed

• Conditions: Cardiomyopathy
• Interventions: Device: CRT-D

• Registration Number: NCT02270840
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

Study Timeline

• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-21
• Study Start: 2014-11
• Primary Completion: 2022-08
• Study Completion: 2022-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CRT-D	CRT-D	Patients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (17)

Central Clinical Hospital of Silesia, Department of Electrocardiology; 🇵🇱 Katowice, Poland

Medical Center Tronik; 🇵🇱 Lodz, Poland

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Medical University of Warsaw; 🇵🇱 Warszawa, Poland

SK-01 National Institute for Cardiovascular Diseases; 🇸🇰 Bratislava, Slovakia

Department of Interventional Cardiology, Medical University of Lodz,; 🇵🇱 Lodz, Poland

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center; 🇭🇺 Budapest, Hungary

Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged; 🇭🇺 Szeged, Csongrád, Hungary

Institute of Cardiology University of Debrecen; 🇭🇺 Debrecen, Hajdú-Bihar, Hungary

Hungarian Institute of Cardiology; 🇭🇺 Budapest, Hungary

University of Pécs Medical School, Heart Institute; 🇭🇺 Pécs, Hungary

Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

Kaplan Medical Center; 🇮🇱 Rehovot, Israel