Heart Failure
Conditions
Keywords
Chronic Heart Failure of Ischemic Origin
Brief summary
Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.
Interventions
BIOLOGICALInjection of C3BS-CQR-1
Injection of the C3BS-CQR-1 using the C-Cath® injection catheter.
BIOLOGICALSham, no injection
Mimic the injection procedure trough insertion of a sham catheter. No injection actually performed
Sponsors
Celyad Oncology SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Eligible patients must meet all of the following inclusion criteria: 1. Age ≥ 18 and \< 80 years. 2. Systolic dysfunction with left ventricular ejection fraction (LVEF) ≤ 35% as assessed by echocardiography. 3. Ischemic heart failure without known need for revascularization. 4. Total MLHFQ score \> 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 or treatment in an outpatient clinic with intravenous vasoactive therapy (including vasodilators, positive inotropic agents and vasopressors) or diuretics for worsening Heart Failure within 12 months prior to screening. 7. Be or must have been within the previous 12 months in New York Heart Association (NYHA) Class III or IV or Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) class 4, 5, 6 or 7, and at the time of inclusion, must be at least in NYHA Class II or greater. 8. Use of ACE inhibitor and/or angiotensin receptor blocker (ARB); and beta blocker, for at least 3 months prior to screening visit, unless intolerant or contraindicated. 9. Stable dosing of ACE inhibitor, angiotensin receptor blocker , 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.
Exclusion criteria
(summarized): Eligible patients must meet none of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy between groups post-index procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and safety between groups post-index procedure | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and safety between groups post-index procedure | 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. |
Countries
Belgium, Bulgaria, Hungary, Israel, Italy, Poland, Serbia, Spain, Switzerland
Outcome results
None listed