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ObesityMITHOMNCT03690076

Human Cardiac Mitochondria in Acute Endocarditis and Obesity

An observational study of Obesity and Endocarditis, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Endocarditis
What is being tested?
Endocarditis
How many people
90 participants
Where
1 siteFrance
Study dates
9 Oct 2018to 30 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adult patients

Who may be able to join

  • 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

Who cannot join

  • Criteria linked to the surgery:
  • Surgery of pressing emergency
  • Aortic dissection
  • Redux surgery
  • Criteria linked to the patient:
  • Protocol refusal
Show all 19Show fewer
  • 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 locations and contacts

1 site in 1 country.

Lise LACLAUTRE contact

0473754963

drci@chu-clermontferrand.fr

France1 site, 1 recruiting

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

    Lise LACLAUTRE, drci@chu-clermontferrand.fr

    Kasra AZARNOUSH

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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
Being tested
Endocarditis, Obese vs. control
Keywords
Heart, Mitochondria, Obesity, Endocarditis
Medical subject headings
Obesity, Endocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndocarditisOther

    Comparison : Endocarditis vs. control

  • Obese vs. controlOther

    Comparisons : Obese vs. control

Study groups in NCT03690076
Study groupRoleWhat they receive
Controlpatients with normal weight (23 < BMI < 27) operated for myocardial revascularization by bypass surgery, without infarction, or for valve pathologies without endocarditis
Receives: Other: Endocarditis
Endocarditispatients with normal weight (23 < BMI < 27) carriers of endocarditis with surgery indication
Receives: Other: Endocarditis
Obeseobese 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
Receives: Other: Obese vs. control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mitochondrial function

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

    Measured: at day 1 (Moment of the surgery)

Secondary outcomes (10)

  1. walk test

    6-minutes walk test

    Measured: at the moment of inclusion in the study (day (-10-5)) and of the end of hospitalization (day +7+10)

  2. body composition

    determination of lean masses by impedance-metry

    Measured: 1 day before the surgery

  3. Electrocardiogram : Detections of the rates in events per min of arrhythmias

    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

    Measured: at days (-10-5), (+7+10), (+30) and (+90)

  4. Membrane lipid composition

    Fatty acid composition of plasma lipids

    Measured: at day 1 (at the day of surgery)

  5. Markers of oxidative stress in the plasma

    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)

    Measured: at days (0) and (+30) for the plasma and day (0) for the myocardium

  6. Concentrations of inflammation cytokines in the plasma

    Inflammatory cytokines in the plasma (IL-6, IL-1b, TNF-a, fibrinogen, CRP and pro-calcitonin

    Measured: at days (-10-5), (0), (+1), (+2), (+7) and (+90)

  7. Semi-quantitative analysis of the amounts of approximatively 6000 molecules in the plasma by metabolomic and lipidomic techniques

    Studies performed in the plasma by a U.S. private society (Metabolon)

    Measured: at days (0) and (+30)

  8. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Exercise testing

    Measured: at day (+30)

  9. Patient follow-up during the hospital stay

    quantity of time (h) spent by the patient during the stay in reanimation

    Measured: morbi-mortality at day (+90)

  10. Morbi-mortality

    rates of deaths and complications (cardiac, renal, hepatic, etc.) during the 90 days following the surgery for all the patients

    Measured: measurement during the post-operative 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2018
  2. Study start9 Oct 2018
  3. Primary completion30 Apr 2020 (estimated)
  4. Study completion30 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03690076
Sponsor's protocol ID
CHU-408
Acronym
MITHOM
Status last verified
Feb 2019
First submitted
20 Sep 2018
Last updated
4 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26255304

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Endocarditis, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise LACLAUTRE (0473754963, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mitochondrial function (time frame: at day 1 (Moment of the surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03690076, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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