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Compare the Effects of Single Versus Repeated Intracoronary Application of Autologous Bone Marrow-derived Mononuclear Cells on Mortality in Patients With Chronic Post-infarction Heart Failure (REPEAT)

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ClinicalTrials.gov Identifier: NCT01693042
Recruitment Status : Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospital

Tracking Information
First Submitted Date  ICMJE September 19, 2012
First Posted Date  ICMJE September 26, 2012
Last Update Posted Date February 26, 2020
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
Mortality at 2 years after inclusion into the study [ Time Frame: 2 years ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
Morbidity at 2 and 5 years after inclusion into the study [ Time Frame: 2 years and 5 years ]
Efficacy endpoints: 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
Safety endpoints: bleeding events, all in-hospital events (during hospitalization for BMC therapy), life-threatening arrhythmias, new malignancies
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
Morbidity at 2 years after inclusion into the study [ Time Frame: 2 years ]
Efficacy endpoints: Comparison between the 2 treatment groups at 2-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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Effects of Single Versus Repeated Intracoronary Application of Autologous Bone Marrow-derived Mononuclear Cells on Mortality in Patients With Chronic Post-infarction Heart Failure
Official Title  ICMJE 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
Brief Summary Single or repeated application of autologous bone marrow-derived stem cells to treat chronic post-infarction heart failure
Detailed Description Improve mortality and morbidity in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy, by single versus repeated intracoronary infusion of autologous bone marrow-derived mononuclear cells.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Biological: intracoronary infusion of autologous bone marrow-derived cells
Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area
Other Name: t2c001
Study Arms  ICMJE
  • Active Comparator: Single intracoronary cell application
    Single intracoronary application of autologous bone marrow derived mononuclear cells
    Intervention: Biological: intracoronary infusion of autologous bone marrow-derived cells
  • Active Comparator: repeated (2 times) intracoronary cell application
    2 times (interval 4 months) intracoronary application of autologous bone marrow derived mononuclear cells
    Intervention: Biological: intracoronary infusion of autologous bone marrow-derived cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 3, 2019)
81
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2012)
676
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 - 80 years
  • written informed consent
  • women of childbearing age: negative pregnancy test; effective contraception for the first 8 months in the trial

Exclusion Criteria:

  • Non-ischemic cardiomyopathy
  • 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), chronic active hepatitis; any chronic inflammatory disease, HIV infection
  • Neoplastic disease without documented remission in the last 5 years
  • Stroke ≤ 3 months
  • Impaired renal function (Serum creatinine > 2,5 mg/dl) 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 mg/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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01693042
Other Study ID Numbers  ICMJE 2011-01-01REPEAT
2011-000595-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A. M. Zeiher, Johann Wolfgang Goethe University Hospital
Study Sponsor  ICMJE Johann Wolfgang Goethe University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas M Zeiher, MD Cardiology, Goethe University Frankfurt
Study Director: Birgit Assmus, MD Cardiology, Goethe University Frankfurt
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP