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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 : Recruiting
First Posted : September 26, 2012
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospital

Brief Summary:
Single or repeated application of autologous bone marrow-derived stem cells to treat chronic post-infarction heart failure

Condition or disease Intervention/treatment Phase
Heart Failure Biological: intracoronary infusion of autologous bone marrow-derived cells Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 676 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Single intracoronary cell application
Single intracoronary application of autologous bone marrow derived mononuclear cells
Biological: intracoronary infusion of autologous bone marrow-derived cells
Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area
Other Name: t2c001
Active Comparator: repeated (2 times) intracoronary cell application
2 times (interval 4 months) intracoronary application of autologous bone marrow derived mononuclear cells
Biological: intracoronary infusion of autologous bone marrow-derived cells
Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area
Other Name: t2c001



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693042


Contacts
Contact: Andreas M Zeiher, MD +49 69 6301 ext 5789 zeiher@em.uni-frankfurt.de
Contact: Birgit Assmus, MD +49 69 6301 ext 7387 b.assmus@em.uni-frankfurt.de

Locations
Germany
Zentralklinik Bad Berka Recruiting
Bad Berka, Germany
Contact: Bernward Lauer, MD       kar@zentralklinik.de   
Contact: Mark Ohlow    036458 51201/-02/-05    marc.ohlow@zentralklinik.de   
Goethe University Frankfurt Recruiting
Frankfurt, Germany, 60590
Contact: Andreas M Zeiher, MD    +49 69 6301 ext 5789    zeiher@em.uni-frankfurt.de   
Contact: Birgit Assmus, MD    +49 69 6301 ext 7387    b.assmus@em.uni-frankfurt.de   
Sub-Investigator: Birgit Assmus, MD         
Principal Investigator: Andreas M Zeiher, MD         
Klinikum Fulda Recruiting
Fulda, Germany
Contact: Volker Schächinger, MD    49 661-84 5380    volker.schaechinger@klinikum-fulda.de   
Contact: Elvira Thielmann    49 661-84 5393    cardio-study@klinikum-fulda.de   
Universitätsklinikum Mainz Not yet recruiting
Mainz, Germany
Contact: Thomas Münzel, MD         
Contact: Tommaso Gori, MD         
Krankenhaus Hetzelstift Not yet recruiting
Neustadt, Germany
Contact: Hubertus von Korn, MD    +49 6321 859 - 4000    h.vonkorn@new.marienhaus-gmbh.de   
Zentralklinikum Suhl Recruiting
Suhl, Germany
Contact: Werner Haberbosch, MD    03681 355400    werner.haberbosch@zs.srh.de   
Contact: Gabriela Günther    03681 355414    gabriela.guenther@zs.srh.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Andreas M Zeiher, MD Cardiology, Goethe University Frankfurt
Study Director: Birgit Assmus, MD Cardiology, Goethe University Frankfurt

Responsible Party: A. M. Zeiher, Prof. Dr. Andreas M. Zeiher, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT01693042     History of Changes
Other Study ID Numbers: 2011-01-01REPEAT
2011-000595-33 ( EudraCT Number )
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by A. M. Zeiher, Johann Wolfgang Goethe University Hospital:
heart failure
old myocardial infarction
bone marrow-derived mononuclear cells
chronic
ischemic

Additional relevant MeSH terms:
Heart Failure
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis