CardiomyopathyNCT02270840
Budapest Upgrade CRT Study (Version 009-4.1)
A study testing CRT-D in people with Cardiomyopathy, run by Semmelweis University Heart and Vascular Center at 17 sites in 7 countries.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- CRT-D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 17 sitesin 7 countries
- Study dates
- Nov 2014to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
Hungary6 sites
Hungarian Institute of Cardiology
Budapest, 1096
Semmelweis University Heart and Vascular Center
Budapest, 1122
Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center
Budapest, 1134
Institute of Cardiology University of Debrecen
Debrecen, Hajdú-Bihar, 4032
University of Pécs Medical School, Heart Institute
Pécs, 7624
Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged
Szeged, Csongrád megye, 6725
Poland4 sites
Central Clinical Hospital of Silesia, Department of Electrocardiology
Katowice, 40-629
Department of Interventional Cardiology, Medical University of Lodz,
Lodz, 90-549
Medical Center Tronik
Lodz, 90-553
Medical University of Warsaw
Warsaw, 02-091
Germany2 sites
Hannover Medical School
Hanover, 30625
Herzzentrum Leipzig GmbH
Leipzig, 04289
Israel2 sites
Barzilai Medical Center
Ashkelon, 78278
Kaplan Medical Center
Rehovot, 76100
Slovakia1 site
SK-01 National Institute for Cardiovascular Diseases
Bratislava, 833 48
About this study
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)
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)
Read the 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.
- Conditions
- Cardiomyopathy
- Being tested
- CRT-D
- Keywords
- cardiac resynchronization therapy
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-DDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| CRT-D | Active comparator | Patients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT. Receives: Device: CRT-D |
| Only ICD | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, Sheba Medical Center, Pharmahungary Group
- Responsible party
- Sponsor
- Investigators
- Valentina Kutyifa, MD, Study director, University of Rochester Medical Center, Rochester, NY, USAIlan Goldenberg, Prof. MD, Study director, Sheba Medical CenterBéla Merkely, Prof. MD, Principal investigator, Semmelweis University Hearth and Vascular Center, Budapest, HungaryAnnamaria Kosztin, MD, Study director, Semmelweis University Hearth and Vascular Center, Budapest, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270840
- Sponsor's protocol ID
- Budapest Upgrade CRT 009-4.1
- Status last verified
- Jun 2023
- First submitted
- 17 Oct 2014
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Merkel E, Hatala R, Szigeti M, Schwertner W, Lakatos B, Behon A, Goscinska-Bis K, Milasinovic G, Papp R, Ruppert M, Saghy L, Clemens M, Solomon SD, Kutyifa V, Kovacs A, Kosztin A, Merkely B. Upgrading Right Ventricular Pacing to Cardiac Resynchronization in HFrEF Patients Improves Symptoms and Functional Outcomes. JACC Heart Fail. 2025 Feb;13(2):265-273. doi: 10.1016/j.jchf.2024.09.011. Epub 2024 Nov 27.
PubMed 39614838Merkely 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.
PubMed 35791276Merkely 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.
PubMed 28339581
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02270840
- Acronym / sponsor ID
- Budapest Upgrade CRT 009-4.1
- Conditions
- Cardiomyopathy
- Keywords
- cardiac resynchronization therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- University of Rochester, Sheba Medical Center, Pharmahungary Group
- Study start
- Nov 2014 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-D | Active comparator | Device: CRT-DPatients currently implanted with a single or dual chamber pacemaker or ICD will be upgraded to CRT. |
| Only ICD | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (19 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT-DBiventricular 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). | Device | CRT-D |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Derived from this study: PubMed 39614838Merkel E, Hatala R, Szigeti M, Schwertner W, Lakatos B, Behon A, Goscinska-Bis K, Milasinovic G, Papp R, Ruppert M, Saghy L, Clemens M, Solomon SD, Kutyifa V, Kovacs A, Kosztin A, Merkely B. Upgrading Right Ventricular Pacing to Cardiac Resynchronization in HFrEF Patients Improves Symptoms and Functional Outcomes. JACC Heart Fail. 2025 Feb;13(2):265-273. doi: 10.1016/j.jchf.2024.09.011. Epub 2024 Nov 27.
- Derived from this study: PubMed 35791276Merkely 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.
- Derived from this study: PubMed 28339581Merkely 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.
- Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Kutyifa, MD study director
University of Rochester Medical Center, Rochester, NY, USA
Ilan Goldenberg, Prof. MD study director
Sheba Medical Center
Béla Merkely, Prof. MD principal investigator
Semmelweis University Hearth and Vascular Center, Budapest, Hungary
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT-D in people with Cardiomyopathy, run by Semmelweis University Heart and Vascular Center at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Hungary, Poland, Germany, Israel, Serbia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270840, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.