Safety and Efficacy of Autologous Cardiopoietic Cells for Treatment of Ischemic Heart Failure. (CHART-1)
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|ClinicalTrials.gov Identifier: NCT01768702|
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Biological: Injection of C3BS-CQR-1 Biological: Sham, no injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||315 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Bone Marrow-derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure.|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Sham Comparator: Control
Sham, no injection
Biological: Sham, no injection
Mimic the injection procedure trough insertion of a sham catheter. No injection actually performed
Experimental: C3BS-CQR-1 Treated
Injection of C3BS-CQR-1
Biological: Injection of C3BS-CQR-1
Injection of the C3BS-CQR-1 using the C-Cath® injection catheter.
- Efficacy between groups post-index procedure [ Time Frame: 39 weeks post-index ]Change between groups from baseline and 39 weeks in a hierarchical composite outcome comprising, from most to least severe outcome, days to death from any cause, number of worsening of heart failure events, change in score for the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (10-point deterioration, no meaningful change,10-point improvement), change in six-minute walk distance (40-m deterioration, no meaningful change, 40-m improvement) and change in left ventricular end systolic volume (15-mL deterioration, no meaningful change, 15-mL improvement), and left ventricular ejection fraction (4% absolute deterioration, no meaningful change, 4% absolute improvement).
- Efficacy and safety between groups post-index procedure [ Time Frame: 52 and 104 weeks post-index ]
Safety: Number and cause of deaths and re-admissions, number of cardiac transplantations, number of myocardial infarctions, number of strokes. Incidence of serious adverse events (AE) through week 104 and non-serious AEs (through week 52).
Efficacy: Time to all cause mortality, time to worsening of heart failure, and time to aborted sudden death through week 52.
- Efficacy and safety between groups post-index procedure [ Time Frame: 39 and 52 weeks post-index ]Time to all cause mortality, time to cardiovascular mortality, and rate of worsening heart failure requiring outpatient IV therapy for heart failure or readmission for heart failure, and others.
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): NCT01768702
|Study Chair:||André Terzic, MD||Mayo Clinic, Division of Cardiovascular Diseases, Rochester (MN, USA)|
|Study Chair:||Jozef Bartunek, MD||OLV Ziekenhuis Aalst (Belgium)|