Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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26 March 2024 |
Main ID: |
EUCTR2011-000595-33-DE |
Date of registration:
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13/09/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Repeated application of bone marrow-derived stem cells to treat chronic post-infarction heart failure
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Scientific title:
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Randomized controlled trial to compare the effects of single versus repeated intracoronary application of autologous bone marrow-derived mononuclear cells on total and SHFM-predicted mortality in patients with chronic post-infarction heart failure
REpetitive Progenitor cEll therapy in Advanced chronic hearT failure (REPEAT trial)
- REPEAT |
Date of first enrolment:
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25/04/2013 |
Target sample size:
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676 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000595-33 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: single versus sequentential treatment Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Netherlands
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Contacts
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Name:
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Cardiology
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Address:
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Theodor-Stern-Kai 7
60590
Frankfurt
Germany |
Telephone:
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+4906963015789 |
Email:
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zeiher@em.uni-frankfurt.de |
Affiliation:
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Goethe University |
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Name:
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Cardiology
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Address:
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Theodor-Stern-Kai 7
60590
Frankfurt
Germany |
Telephone:
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+4906963015789 |
Email:
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zeiher@em.uni-frankfurt.de |
Affiliation:
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Goethe University |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Previous myocardial infarction at least 3 months ago, open infarct vessel or bypass • Left ventricular ejection fraction (LVEF) = 45% on echocardiography • Stable chronic heart failure NYHA class II to III under constant (4 weeks) evidence-based optimal medical treatment • Age > 18 and expected to survive > 1 year • Written informed consent • Women of childbearing age: negative pregnancy test; effective contraception for the first 8 months in the trial
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 176 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria: • Non-ischemic cardiomyopathy • Foreseeable necessity for revascularization in other vessel than the infarct vessel at the time of study therapy • Hemodynamic relevant severe valvular disease with indication for operative / interventional revision • Heart failure with preserved ejection fraction (diastolic heart failure), LVEF > 45% • Unstable Angina • Severe peripheral artery occlusive disease (= Fontaine stadium III) • Active infection (C-reactive protein > 10 mg/dl), any chronic inflammatory disease • Neoplastic disease without documented remission in the last 5 years • Stroke = 3 months • Impaired renal function (Serum creatinine > 2,5 mg/dl or eGRF (MDRD) =30l/ min) at the time of study inclusion • Relevant liver disease (GOT > 2x upper normal limit, spontaneous INR > 1,5). • Diseases of hematopoetic system, anemia (Hemoglobin < 8.5 g/dl), thrombocytopenia < 100.000/µl) • Splenomegaly • Allergy or intolerance of clopidogrel, prasugrel, ticagrelor, heparin, bivalirudin • History of bleeding disorder • Gastrointestinal bleeding = 3 months • Major surgery or trauma = 3 months • Uncontrolled hypertension • Pregnancy, lactation period • Mental retardation • Previous cardiac cell therapy within last 12 months • Participation in another clinical trial = 30 days
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Chronic post-infarction heart failure due to an at least 3 months old myocardial infarction, treated with optimal medication according to the evidence-based guidelines, in NYHA stadium II-III; and with open vessel / bypass sullpying the previously infarcted area
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Intervention(s)
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Product Name: t2c001 Product Code: t2c001 Pharmaceutical Form: Current Sponsor code: t2c001-DS Other descriptive name: Bone marrow-derived progenitor cells Concentration unit: Munit million units Concentration type: range Concentration number: 50-500
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Primary Outcome(s)
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Main Objective: Improve mortality in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy frequently by intracoronary infusion of autologous bone marrow-derived mononuclear cells.
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Secondary Objective: Improve morbidity in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy frequently by intracoronary infusion of autologous bone marrow-derived mononuclear cells.
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Timepoint(s) of evaluation of this end point: 2 years after inclusion into the trial
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Primary end point(s): 2-year observed mortality is significantly lower in patients receiving 2 repeated intracoronary applications of autologous bone marrow-derived cells (t2c001) compared to patients receiving 1 intracoronary application of autologous bone marrow-derived cells (t2c001)
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Secondary Outcome(s)
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Secondary end point(s): Efficacy endpoints: - In patients receiving 2 repeated intracoronary applications of autologous bone marrow-derived cells (t2c001), the observed mortality is significantly lower than the SHFM-predicted mortality at 2-year follow-up
Comparison between the 2 treatment groups at 2-year and 5-year follow-up - Cardiac mortality, cardiovascular mortality - Rehospitalisation for heart failure - Ischemic cardiac events (STEMI, NSTEMI, ACS) - Coronary revascularisations (PCI / CABG) - Heart transplantation, Assist-device implantation - New resynchronization therapy, ICD implantation - NYHA-Status, NT-proBNP serum levels - Minnesota Living with Heart Failure Questionnaire
Prespecified combined clinical endpoints: o Death and rehospitalisation for heart failure o Cardiac Death and rehospitalisation for heart failure o Cardiac and Cardiovascular Death and rehospitalisation for heart failure o Death and myocardial infarction o Death and myocardial infarction and rehospitalisation for heart failure o Death and any cardiovascular event
Safety endpoints: - All in-hospital events (during hospitalization for cell therapy) - Life-threatening arrhythmias (sustained ventricular tachycardia; ventricular fibrillation and cardiopulmonary resuscitation) - Any new malignant disease - Bleeding events - Safety of intracoronary application of autologous bone marrow-derived cells (t2c001) (procedural complications, adverse events at 30 days, SAEs at 4 months after each cell application)
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Timepoint(s) of evaluation of this end point: 2 years after inclusion into the trial
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Secondary ID(s)
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2011-01-01REPEAT
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Source(s) of Monetary Support
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Goethe University Frankfurt
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Ethics review
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Status: Approved
Approval date: 25/04/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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