NCT05632432 Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery
| NCT ID | NCT05632432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital District of Helsinki and Uusimaa |
| Condition | Ischemic Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-04-01 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF). The atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing. In this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the RAA tissue is processed and utilized as epicardially transplanted atrial appendage micrografts (AAMs) for CABG-support therapy. In our preclinical evaluation, epicardial AAMs transplantation after MI attenuated scarring and improved cardiac function. Proteomics suggested an AAMs-induced glycolytic metabolism, a process associated with an increased regenerative capacity of myocardium. Recently, the safety and feasibility of AAMs therapy was demonstrated in an open-label clinical study. Moreover, as this study suggested increased thickness of the viable myocardium in the scarred area, it also provided the first indication of therapeutic benefit. Based on randomization with estimated enrolment of a total of 50 patients with 1:1 group allocation ratio, the piece of RAA tissue is either perioperatively processed to AAMs or cryostored. The AAMs, embedded in a fibrin matrix gel, are placed on a collaged-based matrix sheet, which is then epicardially sutured in place at the end of CABG surgery. The location is determined by preoperative late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI) to pinpoint the ischemic scar. The controls receive the collagen-based patch, but without the AAMs. Study blood samples, transthoracic echocardiography (TTE), and LGE-CMRI are performed before and at 6-month follow-up after the surgery. The trial's primary endpoints focus on changes in cardiac fibrosis as evaluated by LGE-CMRI and circulating levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP). Secondary endpoints center on other efficacy parameters, as well as both safety and feasibility of the therapy.
Eligibility Criteria
Inclusion Criteria: * Informed consent obtained * Left ventricular ejection fraction (LVEF) between ≥ 15% and ≤ 40% at recruitment (transthoracic echocardiography) * New York Heart Association (NYHA) Class II-IV heart failure symptoms Exclusion Criteria: * Heart failure due to left ventricular outflow tract obstruction * Acute myocardial infarction (AMI) within last 30 days * History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator * Stroke or other disabling condition within 3 months before screening * Severe valve disease or scheduled valve surgery * Renal dysfunction (GFR \<45 ml/min/1.73m2) * Other disease limiting life expectancy * Contraindications for coronary angiogram or LGE-CMRI * Participation in some other clinical trial Screening Failure: * After optimization of medications, no visible scar or LVEF ≥ 50% in preoperative LGE-CMRI * Preoperative LGE-CMRI has not been performed prior scheduled CABG
Contact & Investigator
Antti Nykänen, Docent
PRINCIPAL INVESTIGATOR
Hospital District of Helsinki and Uusimaa
Frequently Asked Questions
Who can join the NCT05632432 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ischemic Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05632432 currently recruiting?
Yes, NCT05632432 is actively recruiting participants. Contact the research team at antti.nykanen@hus.fi for enrollment information.
Where is the NCT05632432 trial being conducted?
This trial is being conducted at Helsinki, Finland.
Who is sponsoring the NCT05632432 clinical trial?
NCT05632432 is sponsored by Hospital District of Helsinki and Uusimaa. The principal investigator is Antti Nykänen, Docent at Hospital District of Helsinki and Uusimaa. The trial plans to enroll 50 participants.