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Human Cardiac Mitochondria in Acute Endocarditis and Obesity (MITHOM)

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Endocarditis
Obesity

Treatments

Other: Endocarditis
Other: Obese vs. control

Study type

Observational

Funder types

Other

Identifiers

NCT03690076
CHU-408

Details and patient eligibility

About

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.

Full 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

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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,

Trial design

90 participants in 3 patient groups

Control
Description:
patients with normal weight (23 \< BMI \< 27) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
Treatment:
Other: Endocarditis
Endocarditis
Description:
patients with normal weight (23 \< BMI \< 27) carriers of endocarditis with surgery indication
Treatment:
Other: Endocarditis
Obese
Description:
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
Treatment:
Other: Obese vs. control

Trial contacts and locations

1

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Central trial contact

Lise LACLAUTRE

Data sourced from clinicaltrials.gov

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