- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03690076
Human Cardiac Mitochondria in Acute Endocarditis and Obesity (MITHOM)
February 1, 2019 updated by: University Hospital, Clermont-Ferrand
Development of the Purification of Human Cardiac Mitochondria, Characterization of These Organelles and Validation of the Model in Acute Endocarditis and Obesity
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
3 groups of patients:
- Controls: patients with normal weight (23 < BMI < 27) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
- Endocarditis: patients with normal weight (23 < BMI < 27) carriers of endocarditis with surgery indication
- Obese: obese patients (BMI > 30) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
Comparisons studied:
- Controls vs. endocarditis
- Controls vs. obese patients
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lise LACLAUTRE
- Phone Number: 0473754963
- Email: drci@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- CHU Clermont-Ferrand
-
Contact:
- Lise Laclautre
- Email: drci@chu-clermontferrand.fr
-
Principal Investigator:
- Kasra AZARNOUSH
-
Sub-Investigator:
- Nicolas COMBARET
-
Sub-Investigator:
- Luc DEMAISON
-
Sub-Investigator:
- Thibault LEGER
-
Sub-Investigator:
- Valérie BATEL
-
Sub-Investigator:
- Bruno PEREIRA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adult patients
Description
Inclusion Criteria:
- For the controls : adult patients with normal body weight (23 < BMI < 27) necessitating a cardiac surgery with sternotomy and extracorporeal circulation for myocardial revascularization or valve replacement
- For endocarditis : adult patients with normal body weight (23 < BMI < 27) and endocarditis of bacterial origin necessitating a cardiac surgery with sternotomy and extracorporeal circulation in order to cure a major valve regurgitation or vegetation with higher size than 15 mm with embolic risk
- For obese patients: adult patients with high body weight (BMI > 30 and waist to hip ration > or = 1 for men and 0.85 for women) necessitating a cardiac surgery with sternotomy and extracorporeal circulation for myocardial revascularization or valve replacement
For all the patients:
- Ability to furnish an enlightened agreement
- Menbership of the French social security insurance
Exclusion Criteria:
- Criteria linked to the surgery:
- Surgery of pressing emergency
- Aortic dissection
- Redux surgery
Criteria linked to the patient:
- Protocol refusal
- Protected adult patients
- Previous psychiatric pathology including known addiction states
- Physical or intellectual inability
- Preexisting pathologies such as respiratory failure
- Cardiac failure (ejection fraction < 30% pulmonary hypertenstion > 80 mmHg); aortic counterpulsation; pre-operatory cardiogenic shock
- Severe acute or chronic renal failure with creatinine clearance < 40 ml/min
- Inherited dyslipidemia
- Previous cardiac or thoracic surgery with pericardium opening
- Severe hepatic failure and severe chronic hepatic pathologies
- Evolving neoplasia
- Patients with long course corticoid treatment and with inflammatory diseases
- Patients with double anti-platelet treatment not stopped 48h before the surgery
- Protected people not involved in the study: pregnant women, nursing women, guardianship, deprived of liberty,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
patients with normal weight (23 < BMI < 27) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
|
Comparison : Endocarditis vs. control
|
Endocarditis
patients with normal weight (23 < BMI < 27) carriers of endocarditis with surgery indication
|
Comparison : Endocarditis vs. control
|
Obese
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
|
Comparisons : Obese vs. control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mitochondrial function
Time Frame: at day 1 (Moment of the surgery)
|
Measurement of oxidative phosphorylation and reactive oxygen species release in isolated human cardiac mitochondria
|
at day 1 (Moment of the surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
walk test
Time Frame: at the moment of inclusion in the study (day (-10-5)) and of the end of hospitalization (day +7+10)
|
6-minutes walk test
|
at the moment of inclusion in the study (day (-10-5)) and of the end of hospitalization (day +7+10)
|
body composition
Time Frame: 1 day before the surgery
|
determination of lean masses by impedance-metry
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1 day before the surgery
|
Electrocardiogram : Detections of the rates in events per min of arrhythmias
Time Frame: at days (-10-5), (+7+10), (+30) and (+90)
|
Detections of the rates in events per min of arrhythmias (existence of P wave followed by a QRS complex) and atrio-ventricular blocks in all the patients
|
at days (-10-5), (+7+10), (+30) and (+90)
|
Membrane lipid composition
Time Frame: at day 1 (at the day of surgery)
|
Fatty acid composition of plasma lipids
|
at day 1 (at the day of surgery)
|
Markers of oxidative stress in the plasma
Time Frame: at days (0) and (+30) for the plasma and day (0) for the myocardium
|
Markers of the oxidative stress in the plasma (amounts of thiol groups and TBARS, activities of SOD, catalase, glutathione peroxidase, ratio between the amounts of GSH and GSSG) and in the myocardium (whole myocardium: ratio between the activities of aconitase and fumarase, amount of protein carbonylation; isolated mitochondria: amount of nitrosylated proteins)
|
at days (0) and (+30) for the plasma and day (0) for the myocardium
|
Concentrations of inflammation cytokines in the plasma
Time Frame: at days (-10-5), (0), (+1), (+2), (+7) and (+90)
|
Inflammatory cytokines in the plasma (IL-6, IL-1b, TNF-a, fibrinogen, CRP and pro-calcitonin
|
at days (-10-5), (0), (+1), (+2), (+7) and (+90)
|
Semi-quantitative analysis of the amounts of approximatively 6000 molecules in the plasma by metabolomic and lipidomic techniques
Time Frame: at days (0) and (+30)
|
Studies performed in the plasma by a U.S. private society (Metabolon)
|
at days (0) and (+30)
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: at day (+30)
|
Exercise testing
|
at day (+30)
|
Patient follow-up during the hospital stay
Time Frame: morbi-mortality at day (+90)
|
quantity of time (h) spent by the patient during the stay in reanimation
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morbi-mortality at day (+90)
|
Morbi-mortality
Time Frame: measurement during the post-operative 90 days
|
rates of deaths and complications (cardiac, renal, hepatic, etc.) during the 90 days following the surgery for all the patients
|
measurement during the post-operative 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2018
Primary Completion (Anticipated)
April 30, 2020
Study Completion (Anticipated)
September 30, 2020
Study Registration Dates
First Submitted
September 20, 2018
First Submitted That Met QC Criteria
September 27, 2018
First Posted (Actual)
October 1, 2018
Study Record Updates
Last Update Posted (Actual)
February 4, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-408
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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