Human Cardiac Mitochondria in Acute Endocarditis and Obesity

NCT03690076 | Unknown

• 1 other identifier: CHU-408
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Endocarditis

Keywords

Heart; Mitochondria; Obesity; Endocarditis

Outcome Measures

Primary Outcomes (1)

• Mitochondrial function

  Measurement of oxidative phosphorylation and reactive oxygen species release in isolated human cardiac mitochondria

  at day 1 (Moment of the surgery)

Secondary Outcomes (10)

• 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

Study Arms (3)

Control

patients with normal weight (23 \< BMI \< 27) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis

Other: Endocarditis

Endocarditis

patients with normal weight (23 \< BMI \< 27) carriers of endocarditis with surgery indication

Other: Endocarditis

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

Other: Obese vs. control

Interventions

Endocarditis OTHER

Comparison : Endocarditis vs. control

Control; Endocarditis

Obese vs. control OTHER

Comparisons : Obese vs. control

Obese

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• Université d'Auvergne: collaborator
• Auvergne/Rhône-Alpes area: collaborator
• Heart and Research Foundation: collaborator

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 26255304 BACKGROUND

MeSH Terms

Conditions

Obesity; Endocarditis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Kasra AZARNOUSH

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

0473754963; drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 1, 2018
• Study Start: October 9, 2018
• Primary Completion: April 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

FR (1)