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)

This study is currently recruiting participants.
Verified November 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01693042
First received: September 19, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Mortality at 2 years after inclusion into the study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Morbidity at 2 and 5 years after inclusion into the study [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 676
Study Start Date: November 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Goethe University Frankfurt Not yet 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         
Goethe University; Cardiology Recruiting
Frankfurt, Germany, 60590
Contact: Birgit Assmus, MD    +49 69 6301 ext 7387    b.assmus@em.uni-frankfurt.de   
Principal Investigator: Andreas M Zeiher, MD         
Sub-Investigator: Birgit Assmus, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Andreas M Zeiher, MD Cardiology, Goethe University Frankfurt
Study Director: Birgit Assmus, MD Cardiology, Goethe University Frankfurt
  More Information

No publications provided

Responsible Party: A. M. Zeiher, Prof. Dr. Andreas M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01693042     History of Changes
Other Study ID Numbers: 2011-01-01REPEAT, 2011-000595-33
Study First Received: September 19, 2012
Last Updated: November 14, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Johann Wolfgang Goethe University Hospitals:
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

ClinicalTrials.gov processed this record on April 17, 2014