Heart FailureMITOCH-HFNCT05770349
Ultrastructural Characteristics of Mitochondria in Cardiomyocytes in Heart Failure
An observational study of Heart Failure and Coronary Artery Disease, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Coronary Artery Disease
- What is being tested?
- coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteRussia
- Study dates
- 31 Mar 2023to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 45-60 patients will be included in the study (15-20 people each - in 2023, 2024 and 2025) who meet the stated inclusion and exclusion criteria. The signing of the informed consent will be carried out before the start of any research procedures, the patient will be explained in detail the protocol of the study and the scope of the diagnostic procedures carried out
Who may be able to join
- 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
Who cannot join
- Refusal of revascularization or participation in the study
- Additional cardiac surgery other than coronary bypass surgery (valves, aneurysm)
- Oncological diseases in the active stage;
- The presence of implanted devices (EX, AICD, CT);
- Severe renal dysfunction (GFR <30 ml/min/1.73 m2);
- Infiltrative heart diseases (sarcoidosis, amyloidosis, accumulation diseases);
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, 634050
Elena A Kuzheleva, +79234010502, kea@cardio-tomsk.ru
Alla A Garganeeva, +79138240744, aag@cardio-tomak.ru
About this study
Official title: Association of Ultrastructural Characteristics of Mitochondria in Cardiomyocytes and Signs of Mitochondrial Dysfunction With the Clinical Course and Outcomes of Heart Failure
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.
Read more
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.
Read the detailed description
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.
The results of the study will be obtained by solving the following tasks:
- To investigate the clinical and prognostic significance of mitochondrial dysfunction, confirmed by direct and indirect methods of investigation, in patients with CHF with stenosing atherosclerosis of the coronary arteries who underwent surgical myocardial revascularization in the prospective cohort study;
- To study ultrastructural characteristics of mitochondria of cardiomyocytes from the auricle of the right atrium using a transmission electron microscope JEM-1400 (JEOL, Japan) in patients with CHF with reduced or mildly reduced left ventricular ejection fraction (HFrEF, HFmrEF) and stenosing atherosclerosis of the coronary arteries;
- To evaluate the features of the mitochondrial genome, in particular, to determine whether the mitochondrial DNA belongs to haplogroup K, which may be associated with impaired adaptation to hypoxia due to the negative effect of guanine replacement on adenine at position 9055 (G9055A) [Strauss K.A. et al. Severity of cardiomyopathy associated with adenine nucleotide translocator-1 deficiency correlates with mtDNA haplogroup. Proc Natl Acad Sci U S A. 2013 Feb 26;110(9):3453-8. doi: 10.1073/pnas.1300690110] and its relation to the prognosis of the disease and the ultrastructure of mitochondria according to electron microscopy;
- To study the association of the number of copies of mitochondrial DNA in blood plasma with ultrastructural signs of mitochondrial dysfunction in CMC;
- To evaluate the content of the biochemical marker of mitochondrial damage - cytochrome C in the blood serum of patients with CHF and to identify the correlation of its concentration with the severity of structural and functional changes in mitochondria;
- To assess the significance of the phenomenon of enhanced leaching of the radiopharmaceutical Tc99-MIBI from the myocardium and to determine the degree of correlation of the rate of leaching of Tc99-MIBI with the ultrastructural state of mitochondria, as well as with the clinical course and prognosis of CHF;
- Calculate statistical parameters (sensitivity, specificity, degree of concordance) for each of the indirect signs of mitochondrial dysfunction and their totality in the diagnosis of mitochondrial ultrastructure disorders according to electron microscopy data and prediction of the clinical course and outcomes of CHF in patients undergoing surgical myocardial revascularization.
Thus, it is planned to prove for the first time in the world the association of direct ultrastructural signs of mitochondrial dysfunction with the clinical course and outcomes of CHF in patients who underwent surgical myocardial revascularization. For the first time in the world, the degree of compliance of available indirect signs of mitochondrial dysfunction with the true ultrastructural state of mitochondria will be presented, with the inclusion of 45-60 patients in the study. Based on the results of the study, a parameter or a set of parameters will be proposed that will be most associated with the clinical course of the disease and the outcome in patients with CHF of ischemic etiology.
The results obtained will have high world-class scientific significance and importance, both for fundamental medical science and for the practical implementation of the results.
- Conditions
- Heart Failure, Coronary Artery Disease
- Being tested
- coronary artery bypass grafting
- Keywords
- Chronic heart failure, Mitochondrial function, Mitochondrial DNA, Electron microscopy, SPECT, Cytochrome C, CABG
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypass graftingProcedure or surgery
Coronary artery bypass grafting
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined primary endpoint (percentage)
Combined primary endpoint is calculated as a percentage (%) of patients with one or several outcomes including: cardiovascular death and/or hospitalization for decompensated HF or the need for parenteral administration of a diuretic and/or acute ischemic events or repeated unplanned revascularization and/or unplanned impalement of cardiac implantable electronic devices.
Measured: 12 months
Secondary outcomes (3)
Hospital stay (days)
Number of days of hospitalization following coronary artery bypass grafting (CABG) surgery.
Measured: 30 days
Postoperative complications during hospitalization (percentage)
Postoperative complications during hospitalization are assessed as percentage of patients with complications after CABG.
Measured: 30 days
Incidence of patients with HF worsening (percentage)
Worsening of heart failure (HF) is assessed based on NYHA class change.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start31 Mar 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Russian Science Foundation
- Responsible party
- Principal investigator, Elena A. Kuzheleva, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Alla A Garganeeva, Ph.D., Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770349
- Sponsor's protocol ID
- CRI-241
- Acronym
- MITOCH-HF
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Garganeeva A.A., Kuzheleva E.A., Tukish O.V., Vitt K.N., Andreev S.L., Muslimova E.F., Korepanov V.A., Afanasiev S.A., Gulya M.O., Syromyatnikova E.E., Vladimirova E.A., Stepanov I.V. Possibilities of diagnosis of mitochondrial dysfunction in chronic heart failure. Siberian Journal of Clinical and Experimental Medicine. 2024;39(3):51-57. https://doi.org/10.29001/2073-8552- 2024-39-3-51-57.
Muslimova E.F., Kuzheleva E.A., Garganeeva A.A., Afanasiev S.A. Association of mitochondrial DNA C7028T, G3010A, G9055A polymorphisms and the severity of chronic heart failure of ischemic genesis. Siberian Journal of Clinical and Experimental Medicine. 2025;40(4):123-130. https://doi.org/10.29001/2073-8552-2025-40-4-123-130
Garganeeva AA, Korepanov VA, Kuzheleva EA, Tukish OV, Vitt KN, Muslimova EF, Afanasiev SA. Chronic heart failure with reduced and mildly reduced left ventricle ejection fraction: relationship between mitochondrial respiratory dysfunction of peripheral blood mononuclear cells and iron deficiency. J Geriatr Cardiol. 2025 Sep 28;22(9):812-817. doi: 10.26599/1671-5411.2025.09.004.
PubMed 41143166Garganeeva AA, Kuzheleva EA, Kazakov EP, Syromyatnikova EE, Tukish OV, Kireev II. Association of Cardiomyocyte Mitochondrial Ultrastructure Features with the Severity of Clinical Manifestations in Heart Failure. Kardiologiia. 2026 Jan 14;65(12):13-19. doi: 10.18087/cardio.2025.12.n3062. English, Russian.
PubMed 41531353Kuzheleva EA, Garganeeva AA, Tukish OV, Vitt KN, Andreev SL, Syromyatnikova EE, Vladimirova EA. Total Area of Interfibrillar Mitochondria in the Right Atrial Appendage Cardiomyocytes as an Index of the Functional State of the Cardiovascular System in Chronic Heart Failure. Bull Exp Biol Med. 2025 Feb;178(4):486-490. doi: 10.1007/s10517-025-06361-7. Epub 2025 Mar 26.
PubMed 40138111Garganeeva A.A., Tukish O.V., Kuzheleva E.A., Gulya M.O., Muslimova E.F., Zhargasova V.A., Popov S.V. Heart failure and mitochondrial dysfunction: research methods in experiment and clinical practice. Acta biomedica scientifica. 2025; 10(1): 103-114. doi: 10.29413/ABS.2025-10.1.11
Garganeeva AA, Kuzheleva EA, Tukish OV, Vitt KN, Kondratiev MY, Syromyatnikova EE, Andreev SL, Arsenieva YA, Korepanov VA, Afanasiev SA. Acute Decompensated Heart Failure: Structural and Functional Changes in Mitochondria. Kardiologiia. 2024 Dec 24;64(12):12-18. doi: 10.18087/cardio.2024.12.n2737. English, Russian.
PubMed 39784128Liao M, Men L, Gong M, Li Y, Wang Y, Xu D, Luan J, Zhou H, Liu M, Chen M. Mitophagy: a novel avenue for herbal medicines alleviating myocardial ischemia/reperfusion injury. Apoptosis. 2025 Dec;30(11-12):2676-2693. doi: 10.1007/s10495-025-02178-x. Epub 2025 Sep 12.
PubMed 40938522
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Ultrastructural Characteristics of Mitochondria in Cardiomyocytes and Signs of Mitochondrial Dysfunction With the Clinical Course and Outcomes of Heart Failure
- ClinicalTrials.gov ID
- NCT05770349
- Acronym / sponsor ID
- MITOCH-HF / CRI-241
- Conditions
- Heart Failure, Coronary Artery Disease
- Keywords
- Chronic heart failure, Mitochondrial function, Mitochondrial DNA, Electron microscopy, SPECT, Cytochrome C, CABG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Collaborators
- Russian Science Foundation
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The results of the study will be obtained by solving the following tasks:
- To investigate the clinical and prognostic significance of mitochondrial dysfunction, confirmed by direct and indirect methods of investigation, in patients with CHF with stenosing atherosclerosis of the coronary arteries who underwent surgical myocardial revascularization in the prospective cohort study;
- To study ultrastructural characteristics of mitochondria of cardiomyocytes from the auricle of the right atrium using a transmission electron microscope JEM-1400 (JEOL, Japan) in patients with CHF with reduced or mildly reduced left ventricular ejection fraction (HFrEF, HFmrEF) and stenosing atherosclerosis of the coronary arteries;
- To evaluate the features of the mitochondrial genome, in particular, to determine whether the mitochondrial DNA belongs to haplogroup K, which may be associated with impaired adaptation to hypoxia due to the negative effect of guanine replacement on adenine at position 9055 (G9055A) [Strauss K.A. et al. Severity of cardiomyopathy associated with adenine nucleotide translocator-1 deficiency correlates with mtDNA haplogroup. Proc Natl Acad Sci U S A. 2013 Feb 26;110(9):3453-8. doi: 10.1073/pnas.1300690110] and its relation to the prognosis of the disease and the ultrastructure of mitochondria according to electron microscopy;
- To study the association of the number of copies of mitochondrial DNA in blood plasma with ultrastructural signs of mitochondrial dysfunction in CMC;
- To evaluate the content of the biochemical marker of mitochondrial damage - cytochrome C in the blood serum of patients with CHF and to identify the correlation of its concentration with the severity of structural and functional changes in mitochondria;
- To assess the significance of the phenomenon of enhanced leaching of the radiopharmaceutical Tc99-MIBI from the myocardium and to determine the degree of correlation of the rate of leaching of Tc99-MIBI with the ultrastructural state of mitochondria, as well as with the clinical course and prognosis of CHF;
- Calculate statistical parameters (sensitivity, specificity, degree of concordance) for each of the indirect signs of mitochondrial dysfunction and their totality in the diagnosis of mitochondrial ultrastructure disorders according to electron microscopy data and prediction of the clinical course and outcomes of CHF in patients undergoing surgical myocardial revascularization.
Thus, it is planned to prove for the first time in the world the association of direct ultrastructural signs of mitochondrial dysfunction with the clinical course and outcomes of CHF in patients who underwent surgical myocardial revascularization. For the first time in the world, the degree of compliance of available indirect signs of mitochondrial dysfunction with the true ultrastructural state of mitochondria will be presented, with the inclusion of 45-60 patients in the study. Based on the results of the study, a parameter or a set of parameters will be proposed that will be most associated with the clinical course of the disease and the outcome in patients with CHF of ischemic etiology.
The results obtained will have high world-class scientific significance and importance, both for fundamental medical science and for the practical implementation of the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 45-60 patients will be included in the study (15-20 people each - in 2023, 2024 and 2025) who meet the stated inclusion and exclusion criteria. The signing of the informed consent will be carried out before the start of any research procedures, the patient will be explained in detail the protocol of the study and the scope of the diagnostic procedures carried out
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Refusal of revascularization or participation in the study
- Additional cardiac surgery other than coronary bypass surgery (valves, aneurysm)
- Oncological diseases in the active stage;
- The presence of implanted devices (EX, AICD, CT);
- Severe renal dysfunction (GFR <30 ml/min/1.73 m2);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary artery bypass graftingCoronary artery bypass grafting | Procedure or surgery | – |
Primary outcome
Combined primary endpoint (percentage)
Time frame: 12 months
Combined primary endpoint is calculated as a percentage (%) of patients with one or several outcomes including: cardiovascular death and/or hospitalization for decompensated HF or the need for parenteral administration of a diuretic and/or acute ischemic events or repeated unplanned revascularization and/or unplanned impalement of cardiac implantable electronic devices.
3 secondary outcomes
Hospital stay (days)
Time frame: 30 days
Postoperative complications during hospitalization (percentage)
Time frame: 30 days
Incidence of patients with HF worsening (percentage)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- BackgroundGarganeeva A.A., Kuzheleva E.A., Tukish O.V., Vitt K.N., Andreev S.L., Muslimova E.F., Korepanov V.A., Afanasiev S.A., Gulya M.O., Syromyatnikova E.E., Vladimirova E.A., Stepanov I.V. Possibilities of diagnosis of mitochondrial dysfunction in chronic heart failure. Siberian Journal of Clinical and Experimental Medicine. 2024;39(3):51-57. https://doi.org/10.29001/2073-8552- 2024-39-3-51-57.
- BackgroundMuslimova E.F., Kuzheleva E.A., Garganeeva A.A., Afanasiev S.A. Association of mitochondrial DNA C7028T, G3010A, G9055A polymorphisms and the severity of chronic heart failure of ischemic genesis. Siberian Journal of Clinical and Experimental Medicine. 2025;40(4):123-130. https://doi.org/10.29001/2073-8552-2025-40-4-123-130
- Background: PubMed 41143166Garganeeva AA, Korepanov VA, Kuzheleva EA, Tukish OV, Vitt KN, Muslimova EF, Afanasiev SA. Chronic heart failure with reduced and mildly reduced left ventricle ejection fraction: relationship between mitochondrial respiratory dysfunction of peripheral blood mononuclear cells and iron deficiency. J Geriatr Cardiol. 2025 Sep 28;22(9):812-817. doi: 10.26599/1671-5411.2025.09.004.
- Background: PubMed 41531353Garganeeva AA, Kuzheleva EA, Kazakov EP, Syromyatnikova EE, Tukish OV, Kireev II. Association of Cardiomyocyte Mitochondrial Ultrastructure Features with the Severity of Clinical Manifestations in Heart Failure. Kardiologiia. 2026 Jan 14;65(12):13-19. doi: 10.18087/cardio.2025.12.n3062. English, Russian.
- Background: PubMed 40138111Kuzheleva EA, Garganeeva AA, Tukish OV, Vitt KN, Andreev SL, Syromyatnikova EE, Vladimirova EA. Total Area of Interfibrillar Mitochondria in the Right Atrial Appendage Cardiomyocytes as an Index of the Functional State of the Cardiovascular System in Chronic Heart Failure. Bull Exp Biol Med. 2025 Feb;178(4):486-490. doi: 10.1007/s10517-025-06361-7. Epub 2025 Mar 26.
- BackgroundGarganeeva A.A., Tukish O.V., Kuzheleva E.A., Gulya M.O., Muslimova E.F., Zhargasova V.A., Popov S.V. Heart failure and mitochondrial dysfunction: research methods in experiment and clinical practice. Acta biomedica scientifica. 2025; 10(1): 103-114. doi: 10.29413/ABS.2025-10.1.11
- Background: PubMed 39784128Garganeeva AA, Kuzheleva EA, Tukish OV, Vitt KN, Kondratiev MY, Syromyatnikova EE, Andreev SL, Arsenieva YA, Korepanov VA, Afanasiev SA. Acute Decompensated Heart Failure: Structural and Functional Changes in Mitochondria. Kardiologiia. 2024 Dec 24;64(12):12-18. doi: 10.18087/cardio.2024.12.n2737. English, Russian.
- Derived from this study: PubMed 40938522Liao M, Men L, Gong M, Li Y, Wang Y, Xu D, Luan J, Zhou H, Liu M, Chen M. Mitophagy: a novel avenue for herbal medicines alleviating myocardial ischemia/reperfusion injury. Apoptosis. 2025 Dec;30(11-12):2676-2693. doi: 10.1007/s10495-025-02178-x. Epub 2025 Sep 12.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alla A Garganeeva, Ph.D. principal investigator
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Coronary Artery Disease, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena A Kuzheleva, Ph.D. (+79234010502, kea@cardio-tomsk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined primary endpoint (percentage) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05770349, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.