Heart Failure Clinical Trial
Official title:
Regeneration of Ischemic Damages in Cardiovascular System Using Wharton's Jelly as an Unlimited Source of Mesenchymal Stem Cells for Regenerative Medicine. Project of the National Centre for Research and Development (Poland) 'STRATEGMED II'. Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)
Verified date | April 2021 |
Source | John Paul II Hospital, Krakow |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will receive the placebo.
Status | Completed |
Enrollment | 115 |
Est. completion date | March 31, 2021 |
Est. primary completion date | January 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Poland | The John Paul II Hospital | Cracovia | |
Poland | The University Hospital in Cracow | Cracovia | |
Poland | Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego | Katowice | |
Poland | Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice | Katowice | |
Poland | Central Clinical Hospital of the MSWiA in Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
John Paul II Hospital, Krakow | KCRI, National Center for Research and Development, Poland |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricle ejection fraction (LVEF) increase | 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). | 6 months FU | |
Secondary | An increase the result of 6 minute walk test | An increase the result of 6 minute walk test at 3 and 6 month. | 3 and 6 month FU | |
Secondary | Myocardial perfusion improvement | Myocardial perfusion improvement assessed in SPECT at 6 month FU. | 6 month FU | |
Secondary | Myocardial perfusion improvement | Myocardial perfusion improvement assessed in cardiac MRI at 6 month FU. | 6 month FU | |
Secondary | An improvement the result of spiroergometric test | An improvement the result of spiroergometric test at 6 month FU. | 6 month FU | |
Secondary | Left ventricle ejection fraction (LVEF) change against baseline | Left ventricle ejection fraction (LVEF) change (in %) against baseline, assessed in echocardiography. | 6 month FU | |
Secondary | Left ventricle end-systolic volume (ESV) change against baseline | Left ventricle end-systolic volume (ESV, in ml) change against baseline, assessed in echocardiography. | 6 month FU | |
Secondary | Left ventricle end-diastolic volume (EDV) change against baseline | Left ventricle end-diastolic volume (EDV, in ml) change against baseline, assessed in echocardiography. | 6 month FU | |
Secondary | NT pro-BNP level | NT pro-BNP level at 3, 6 and 12 months in comparison to the baseline level. | 3, 6 and 12 months FU | |
Secondary | The occurrence of major adverse cardiovascular events | The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure) at 6 month and 1 year FU. | 6 month and 1 year FU | |
Secondary | Quality of life improvement | Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population at 6 month and 1 year FU. | 6 month and 1 year FU |
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