Chronic advanced symptomatic heart failure secondary to ischemic cardiomyopathy MedDRA version: 14.1 Level: LLT Classification code 10010684 Term: Congestive heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: C3BS-CQR-1
Product Code: C3BS-CQR-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Autologous bone marrow-derived cardio
Sponsors
Cardio3 BioSciences SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients must meet all of the following inclusion criteria: 1. Age = 18 and 30. 5. Ability to perform a 6 minute walk test > 100 m and = 400 m. 6. History of hospitalization for heart failure (HF) within 12 months prior to screening. 7. NYHA Class III or IV despite optimal standard of care or INTERMACS class 4, 5, 6 or 7. 8. Use of ACE inhibitor and/or ARB; and beta blocker, for at least 3 months prior to screening visit, unless intolerant or contraindicated. 9. Stable dosing of ACE inhibitor, ARB, beta blocker, aldosterone blocker, and diuretics for at least one month prior to screening visit, defined as = 50% change in total dose of each agent. 10. Willing and able to give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: Eligible patients must meet none of the following exclusion criteria: 1. Women who are pregnant, confirmed by a positive urine or serum hCG laboratory test at screening. 2. Women of child-bearing potential without a negative serum or urine pregnancy test at screening or who are not practicing a reliable form of birth control. Women who are postmenopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level > 40 IU/m or 6 weeks post surgical bilateral oophorectomy) or surgically sterile are not considered to be of child-bearing potential. Reliable contraception includes surgical sterilization, hormonal contraception, or double-barrier methods. 3. Men refusing to exercise a reliable form of contraception. 4. Myocardial infarction, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening, or CABG surgery within 180 days prior to screening. 5. Patient on a cardiac transplant list or previously received any solid organ transplant. 6. Previously underwent cardiac surgery with remodeling procedure, left ventricular assist device placement or cardiomyoplasty. 7. Patient has undergone cardiac resynchronization therapy (CRT) within 6 months prior to screening. 8. Severe uncontrolled HF requiring need for intensive intravenous diuretics or inotropic support within 1 month prior to screening. 9. Inability to perform a 6 minute walk test due to physical limitations other than HF including: (a.) Severe peripheral vascular disease (b.) Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise (c.) Orthopedic limitations, severe muscular diseases, any other joint or muscular disease or neurological disorder (such as an old stroke or neuropathy) limiting the ability to walk for 6 minutes. 10. Dependence on chronic oral steroid therapy. 11. Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening. 12. Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy. 13. BMI 45. 14. Left ventricular thrombus. 15. Left ventricular wall thickness 3.0 mg/dL or is currently on dialysis. 23. Hematocrit < 28%. 24. Atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree that could impede or preclude the safe retrograde passage of the delivery catheter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of C3BS-CQR-1 by comparing the overall response to C3BS-CQR-1 relative to standard of care undergoing a sham procedure using a composite outcome of morbidity and mortality, changes in quality of life , six-minute walk distance, and left ventricular structure and function at 39 weeks (9 months) post-procedure.; Secondary Objective: The secondary objective is to assess the safety of C3BS-CQR-1 by comparing the incidence of serious adverse events between study groups at 52 weeks (12 months) post-procedure and all cause mortality at 104 weeks (24 months) post-procedure. Additionally data will be collected to evaluate the safety and performance of the endoventricular injection catheter C-Cath® as a system for delivery of C3BS-CQR-1 into the left ventricular myocardium. ; Primary end point(s): The primary efficacy endpoint will measure the efficacy of C3BS-CQR-1 injection at 39 weeks (9 months) based on a hierarchical composite of: 1. All-cause mortality. 2. Worsening of heart failure events requiring intensive care with intravenous diuretics or inotropic support or readmission. 3. Change in MLHFQ total score. 4. Change in Six-minute walk distance. 5. Change in LVESV as assessed by echocardiography 6. Change in LVEF as assessed by echocardiography. ;Timepoint(s) of evaluation of this end point: At 39 weeks (9 months) post index procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints will include the following: 1. The occurrence of the following clinical events through 52 and 104 weeks (12 and 24 months): death and cause of death, re-admissions and cause of re-admission, cardiac transplantation, myocardial infarction, stroke. 2. Incidence of serious adverse events through 52 and 104 weeks (12 and 24 months) post index procedure. 3. Incidence of non-serious adverse events through 52 weeks post index procedure. Secondary efficacy endpoints will include the effect of C3BS-CQR-1 injection at 52 weeks (12 months) on: 1. Time to all cause mortality. 2. Worsening of heart failure events requiring intensive care with intravenous diuretics or inotropic support or readmission. 3. Aborted sudden death events, defined as resuscitated sudden death or appropriate Automatic Implantable Cardioverter Defibrillator (AICD) firing for severe ventricular tachyarrhythmias. Tertiary (explorative) efficacy endpoints will include the effect of C3BS-CQR-1 injection on each of the components of the composite endpoint at 39, and 52 weeks (9 and 12 months) unless otherwise specified: 1. Time to all cause mortality. 2. Time to cardiovascular (CV) mortality. 3. Worsening of HF requiring outpatient IV therapy for HF or readmission for HF. 4. Aborted sudden death events, defined as resuscitated sudden death or appropriate AICD firing for severe ventricular tachyarrhythmias. 5. Re-admissions for heart failure. 6. Worsening of HF requiring outpatient IV therapy for HF. 7. Total days alive out of hospital. 8. Change in Six-minute walk distance from pre-procedure. 9. Change in MLWHF Questionnaire from pre-procedure. 10. Change in LVESV, | — |
Countries
Belgium, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Ireland, Israel, Italy, Lithuania, Poland, Serbia, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactClinical Trial Information
Cardio3 BioSciences SA
Outcome results
None listed