MITHOM
Development of the Purification of Human Cardiac Mitochondria, Characterization of These Organelles and Validation of the Model in Acute Endocarditis and Obesity
Sponsor study identifier
observational
90
1 country
1
Study Start
October 9, 2018
Actual (reported)Primary Completion
April 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Data about human cardiac mitochondria are cruelly lacking in the literature. However, damages of the activity of these organelles are often the source of abnormal cardiac function in several pathologies. The purpose of this study is to develop a model of purified human cardiac mitochondria, to verify the purity of these organelles and to validate the authenticity of their function in acute endocarditis and obesity, two situations known to alter their activity. Animal studies have shown that microbial infection reduced mitochondrial metabolism whereas obesity increases it. The investigator's hypotheses are the following: 1) acute endocarditis, a form of cardiac microbial infection, reduces the function of human cardiac mitochondria; 2) obesity (body mass index \> 30) activates the metabolism of human cardiac mitochondria.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2018
Actual (reported)October 1, 2018
Actual (reported)October 9, 2018
Actual (reported)April 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mitochondrial function
Measurement of oxidative phosphorylation and reactive oxygen species release in isolated human cardiac mitochondria
at day 1 (Moment of the surgery)
walk test
at the moment of inclusion in the study (day (-10-5)) and of the end of hospitalization (day +7+10)
body composition
1 day before the surgery
Electrocardiogram : Detections of the rates in events per min of arrhythmias
at days (-10-5), (+7+10), (+30) and (+90)
Membrane lipid composition
at day 1 (at the day of surgery)
Markers of oxidative stress in the plasma
at days (0) and (+30) for the plasma and day (0) for the myocardium
patients with normal weight (23 \< BMI \< 27) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
patients with normal weight (23 \< BMI \< 27) carriers of endocarditis with surgery indication
obese patients (BMI \> 30 with waist to hip ratio \> or = 1 in men and 0.85 in women) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
Comparison : Endocarditis vs. control
Comparisons : Obese vs. control
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
adult patients
Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
Mourmoura E, Rigaudiere JP, Couturier K, Hininger I, Laillet B, Malpuech-Brugere C, Azarnoush K, Demaison L. Long-term abdominal adiposity activates several parameters of cardiac energy function. J Physiol Biochem. 2016 Sep;72(3):525-37. doi: 10.1007/s13105-015-0427-7. Epub 2015 Aug 10.
Kasra AZARNOUSH
University Hospital, Clermont-Ferrand
First Submitted
September 20, 2018
First Posted
October 1, 2018
Study Start
October 9, 2018
Actual (reported)Primary Completion
April 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 4, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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