Examining Mitochondria in Heart Cells of Heart Failure Patients
Association of Ultrastructural Characteristics of Mitochondria in Cardiomyocytes and Signs of Mitochondrial Dysfunction With the Clinical Course and Outcomes of Heart Failure
This study looks at the tiny parts of heart cells in people with heart failure to see how their health affects the progression of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences Academic / other |
| Locations | 1 site (Tomsk) |
| Trial ID | NCT05770349 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the ultrastructural characteristics of mitochondria in cardiomyocytes from patients with chronic heart failure (CHF) and coronary artery disease. It will focus on understanding how mitochondrial dysfunction relates to the clinical progression of CHF, particularly in patients undergoing coronary artery bypass grafting. The study will involve a cohort of 45 to 60 patients, analyzing mitochondrial features through advanced imaging techniques. By correlating structural changes with clinical outcomes, the research seeks to clarify the role of mitochondrial health in heart failure.
Who should consider this trial
Good fit: Ideal candidates include adults with heart failure with reduced or mid-range ejection fraction and obstructive multivessel coronary atherosclerosis requiring surgical intervention.
Not a fit: Patients with active oncological diseases, severe renal dysfunction, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of mitochondrial dysfunction in heart failure, potentially leading to improved treatment strategies.
How similar studies have performed: While studies on mitochondrial dysfunction in heart failure exist, this specific approach focusing on ultrastructural characteristics in a large cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The presence of HFrEF or HFmrEF (EF of LV \<50%) 2. Obstructive multivessel coronary atherosclerosis as an indication for cardiac surgical correction of coronary blood flow (coronary bypass surgery) 3. Signed informed consent to participate in the study, separate consents for biomaterial sampling and genetic research Exclusion Criteria: 1. Refusal of revascularization or participation in the study 2. Additional cardiac surgery other than coronary bypass surgery (valves, aneurysm) 3. Oncological diseases in the active stage; 4. The presence of implanted devices (EX, AICD, CT); 5. Severe renal dysfunction (GFR \<30 ml/min/1.73 m2); 6. Infiltrative heart diseases (sarcoidosis, amyloidosis, accumulation diseases); 7. Autoimmune diseases; 8. Acute infectious and exacerbations of chronic somatic diseases 9. Type 1 or type 2 diabetes mellitus 10. Contraindications to myocardial scintigraphy, cardiopulmonary stress test 11. Impossibility of prescribing optimal drug therapy after cardiac surgery
Where this trial is running
Tomsk
- Tomsk National Research Medical Center, Russian Academy of Sciences — Tomsk, Russia (Recruiting)
Study contacts
- Principal investigator: Alla A Garganeeva, Ph.D. — Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
- Study coordinator: Elena A Kuzheleva, Ph.D.
- Email: kea@cardio-tomsk.ru
- Phone: +79234010502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.