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Ultrastructural Characteristics of Mitochondria in Cardiomyocytes in Heart Failure

Study acronym: MITOCH-HF
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 14 words
    • Study description expanded, about 7 words
    • Publications: details revised at 8 of 8 entries
  2. Minor Publications: details revised at 6 of 8 entriesv7
  3. Notable Primary completion date: Feb 2026 to Nov 2026v6 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: Feb 2027 to Nov 2027
    • Secondary endpoints: 9 to 3
    • Publications: 2 to 8
  4. Minor 2 versions Re-verified since May 1, 2024, no change to tracked fieldsv4-v5
  5. Minor Start date changed from estimate of Mar 2023 to Mar 31, 2023v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05770349
Lead Sponsor Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborators: Russian Science Foundation
Conditions
(from sponsor)
Heart Failure, Coronary Artery Disease
Related terms Coronary Artery Disease, Heart Failure
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov