Chronic Ischaemic Heart Failure (CIHF) MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Sponsors
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18-80 years - Diagnosis of ischemic heart failure (supported by history of CAD or revascularization by PCI or CABG procedure) without known need for revascularization or feasibility of revascularization - Substantial chronic ischemic myocardial injury as demonstrated by LVEF =45% by SPECT and the clinical stage of NYHA II or III - At least 50% viable myocardium (SPECT) - Patency of at least two major coronary arteries and/or bypass grafts supplying their territories (confirmed in angiography within 12 months) - Clinically stable CIHF for at least 3 months on guideline recommended therapy - Signed 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 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115
Exclusion criteria
Exclusion criteria: - Other than ischemic cause of cardiomyopathy - Less than 3 months from any substantial therapeutic intervention (such as, e.g. CRT/ICD fitting or revascularization) - Less than 3 months from ACS - BMI lower than 18 or greater than 45kg/m2 - Severe valvular heart disease or left ventricle aneurysm requiring aneurysmectomy or other structural interventions - Candidate for heart transplantation - Active or any history of malignancy or tumor - Moderate or severe immunodeficiency - Chronic immunosuppressive therapy - Acute or chronic infection - Coagulopathies - Known alcohol or drug dependence - Severe renal dysfunction (eGFR<20mL/min) - Soft tissue disease or local infection in a place of required artery puncture - Pregnancy or breastfeeding - Females of childbearing potential who do not use a highly effective method of contraception - Females of childbearing potential in absence of a negative highly sensitive urine or serum pregnancy test - Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this project - Life expectancy < 12 months - Any objective or subjective reason for inability to attend follow-up visits - Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the regenerative capacity of CardioCell in patients with Chronic Ischaemic Heart Failure (CIHF) based on the evaluation of Left ventricle ejection fraction assessed by SPECT ;Secondary Objective: Evaluation of the regenerative capacity of CardioCell in patients with Chronic Ischaemic Heart Failure (CIHF) based on the results from echocardiography, MRI, 6MWT, ergospirometry, ECG, QoL.;Primary end point(s): Left ventricle ejection fraction (LVEF) increase, assessed by SPECT at 6M FU vs. during index (baseline) imaging – comparison between two groups (active vs placebo therapy);Timepoint(s) of evaluation of this end point: 6 month follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3, 6 and 12 months FU visit;Secondary end point(s): 1. An increase the result of 6 minute walk test at 3 and 6 month. 2. Myocardial perfusion improvement assessed in SPECT at 6 month FU. 3. Myocardial perfusion improvement assessed in cardiac MRI at 6 month FU. 4. An improvement the result of spiroergometric test at 6 month FU. 5. Left ventricle ejection fraction (LVEF), end-systolic volume (ESV) and end-diastolic volume (EDV) change against baseline, assessed in echocardiography at 3, 6, 9 and 12 months FU. 6. NT pro-BNP level at 3, 6 and 12 months in comparison to the baseline level. 7. The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure) at 6 month and 1 year FU. 8. Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at 6 month and 1 year FU. | — |
Countries
Poland
Contacts
Public ContactGasior
Ewa
Outcome results
None listed