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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)

Primary Purpose

Heart Failure

Status

Active

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

intracoronary infusion of autologous bone marrow-derived cells

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, old myocardial infarction, bone marrow-derived mononuclear cells, chronic, ischemic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zentralklinik Bad Berka
Goethe University Frankfurt
Klinikum Fulda
Universitätsklinikum Mainz
Krankenhaus Hetzelstift
Zentralklinikum Suhl

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Single intracoronary cell application

repeated (2 times) intracoronary cell application

Arm Description

Single intracoronary application of autologous bone marrow derived mononuclear cells

2 times (interval 4 months) intracoronary application of autologous bone marrow derived mononuclear cells

Outcomes

Primary Outcome Measures

Mortality at 2 years after inclusion into the study

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

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

Full Information

NCT ID

NCT01693042

First Posted

September 19, 2012

Last Updated

February 25, 2020

Sponsor

Johann Wolfgang Goethe University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01693042

Brief Title

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

Acronym

REPEAT

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 Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2013 (undefined)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

heart failure, old myocardial infarction, bone marrow-derived mononuclear cells, chronic, ischemic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single intracoronary cell application

Arm Type

Active Comparator

Arm Description

Single intracoronary application of autologous bone marrow derived mononuclear cells

Arm Title

repeated (2 times) intracoronary cell application

Arm Type

Active Comparator

Arm Description

2 times (interval 4 months) intracoronary application of autologous bone marrow derived mononuclear cells

Intervention Type

Biological

Intervention Name(s)

intracoronary infusion of autologous bone marrow-derived cells

Other Intervention Name(s)

t2c001

Intervention Description

Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area

Primary Outcome Measure Information:

Title

Mortality at 2 years after inclusion into the study

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Morbidity at 2 and 5 years after inclusion into the study

Description

Time Frame

2 years and 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas M Zeiher, MD

Organizational Affiliation

Cardiology, Goethe University Frankfurt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Birgit Assmus, MD

Organizational Affiliation

Cardiology, Goethe University Frankfurt

Official's Role

Study Director

Facility Information:

Facility Name

Zentralklinik Bad Berka

City

Bad Berka

Country

Germany

Facility Name

Goethe University Frankfurt

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Klinikum Fulda

City

Fulda

Country

Germany

Facility Name

Universitätsklinikum Mainz

City

Mainz

Country

Germany

Facility Name

Krankenhaus Hetzelstift

City

Neustadt

Country

Germany

Facility Name

Zentralklinikum Suhl

City

Suhl

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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