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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01693042
• Other study ID #: 2011-01-01REPEAT
• Secondary ID: 2011-000595-33
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2013
• Est. completion date: January 2025

Study information

• Verified date: February 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: January 2025
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Infarction

Intervention

Biological:
• intracoronary infusion of autologous bone marrow-derived cells
Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Goethe University Frankfurt	Frankfurt
Germany	Klinikum Fulda	Fulda
Germany	Universitätsklinikum Mainz	Mainz
Germany	Krankenhaus Hetzelstift	Neustadt
Germany	Zentralklinikum Suhl	Suhl

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years
Secondary	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	2 years and 5 years