NCT05770349Recruiting
Ultrastructural Characteristics of Mitochondria in Cardiomyocytes in Heart Failure
Association of Ultrastructural Characteristics of Mitochondria in Cardiomyocytes and Signs of Mitochondrial Dysfunction With the Clinical Course and Outcomes of Heart Failure
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
According to modern concepts, mitochondrial dysfunction may be the fundamental basis for the development and progression of CHF, including in patients undergoing myocardial revascularization. The processes of mitochondrial fusion, division and mitophagy are aimed at maintaining cellular homeostasis. A change in the balance of these processes can lead to the accumulation of damaged organelles with impaired functions. In patients with CHF, dysfunctional mitochondria are characterized by size dispersion, crist disorganization, and localization changes relative to myofibrils. At the same time, the topic of the influence of mitochondrial dysfunction on the prognosis and clinical course of CHF remains debatable today. Direct study of the structural and functional features of mitochondria in human cardiomyocytes is an extremely difficult task, and therefore, such studies are carried out extremely rarely and on very limited cohorts. In the planned study, due to the long time of the study material recruitment, the ultrastructure of mitochondria in a large cohort of patients, ranging from 45 to 60 people, will be studied. The aim of this study is to study the association of mitochondrial dysfunction with the clinical course and outcomes of CHF of ischemic etiology, as well as to assess the degree of compliance of indirect criteria of mitochondrial dysfunction with direct ultrastructural characteristics of mitochondria in cardiomyocytes. This single-center prospective cohort study will involve 45-60 patients. The patients will have biopsy samples taken from the right auricle, as well as blood collection and preservation and its derivatives. Electron microscopy of myocardial samples will be performed to assess the ultrastructure of mitochondria of cardiomyocytes. The results of a direct study of mitochondria will be compared with indirect signs of mitochondrial dysfunction: the registration of the phenomenon of increased leaching of radiopharmaceuticals from the myocardium, an increase in the number of copies of mitochondrial DNA and the concentration of cytochrome C in the blood, the affiliation of mitochondrial DNA to haplogroup K. The results obtained in each of the research tasks will have high scientific significance and publication potential.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 45 (estimated)
- First submitted
- 21 Feb 2023
- Start date
- 31 Mar 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT05770349
What you commit to
- Study type: Observational
- Planned participants: 45
- From 31 Mar 2023 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Additional cardiac surgery other than coronary bypass surgery (valves, aneurysm)
- Oncological diseases in the active stage;
- Infiltrative heart diseases (sarcoidosis, amyloidosis, accumulation diseases);
- Autoimmune diseases;
- Acute infectious and exacerbations of chronic somatic diseases
- Type 1 or type 2 diabetes mellitus
- Contraindications to myocardial scintigraphy, cardiopulmonary stress test
- Impossibility of prescribing optimal drug therapy after cardiac surgery
Lab values
- Severe renal dysfunction (GFR \<30 ml/min/1.73 m2);
Other
- Refusal of revascularization or participation in the study
- The presence of implanted devices (EX, AICD, CT);
Who the study is looking for
- The presence of HFrEF or HFmrEF (EF of LV \<50%)
- Obstructive multivessel coronary atherosclerosis as an indication for cardiac surgical correction of coronary blood flow (coronary bypass surgery)
- Signed informed consent to participate in the study, separate consents for biomaterial sampling and genetic research
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tomsk National Research Medical Center, Russian Academy of Sciences Coordinator of this site? Confirm its status | Tomsk | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.