Status:
COMPLETED
Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)
Lead Sponsor:
John Paul II Hospital, Krakow
Collaborating Sponsors:
KCRI
National Center for Research and Development, Poland
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 rece...
Detailed Description
The CIHF trial will enroll 105 patients with randomization into active and placebo therapy with 2:1 ratio. Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03418233
Start Date
April 19 2018
End Date
March 31 2021
Last Update
April 9 2021
Active Locations (5)
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1
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
Katowice, Poland, 04-628
2
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Katowice, Poland, 40-635
3
The John Paul II Hospital
Krakow, Poland, 31-202
4
The University Hospital in Cracow
Krakow, Poland, 31-501