Budapest Upgrade CRT Study (Version 009-4.1)

Cardiomyopathy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270840
• Other study ID #: Budapest Upgrade CRT 009-4.1
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: August 2022

Study information

• Verified date: June 2023
• Source: Semmelweis University Heart and Vascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

Intervention

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).

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover
Germany	Herzzentrum Leipzig GmbH	Leipzig
Hungary	Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center	Budapest
Hungary	Hungarian Institute of Cardiology	Budapest
Hungary	Semmelweis University Heart and Vascular Center	Budapest
Hungary	Institute of Cardiology University of Debrecen	Debrecen	Hajdú-Bihar
Hungary	University of Pécs Medical School, Heart Institute	Pécs
Hungary	Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged	Szeged	Csongrád
Israel	Barzilai Medical Center	Ashkelon
Israel	Kaplan Medical Center	Rehovot
Poland	Central Clinical Hospital of Silesia, Department of Electrocardiology	Katowice
Poland	Department of Interventional Cardiology, Medical University of Lodz,	Lodz
Poland	Medical Center Tronik	Lodz
Poland	Medical University of Warsaw	Warszawa
Serbia	Clinical Center of Serbia	Belgrade
Slovakia	SK-01 National Institute for Cardiovascular Diseases	Bratislava
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (4)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center	Pharmahungary Group, Sheba Medical Center, University of Rochester

Countries where clinical trial is conducted

Germany,  Hungary,  Israel,  Poland,  Serbia,  Slovakia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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