Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction

July 9, 2019 updated by: University Hospital, Lille
The investigators aim to explore obese cardiomyopathy by studying contractile twitch force, sarcomere sensitivity to calcium and mitochondrial function in atrial myocardial samples of patients grouped according to their body mass index, i.e. normal weight, overweight and obese.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is associated with the development of heart failure, regardless of coronary artery disease or other comorbidities.

Right atrial samples obtained from patients undergoing cardiac surgery and presenting no sign of clinical cardiomyopathy will be grouped according to patient's body mass index. Atrial trabeculae will be explored to dissect out the respective contribution of (i) sarcoplasmic reticulum dysfunction (isometric twitch force contraction analysis), (ii) abnormal sarcomere sensitivity to calcium assessed in permeabilized fibers and (iii) mitochondrial dysfunction to intrinsec contractile dysfunction of myocardium in obese patients.

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Cardiologique - EFCV - CHRU

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

consecutive patients undergoing coronary artery bypass graft surgery or aortic valve replacement surgery with extracorporeal circulation

Description

Inclusion Criteria:

  • patient schedulled for coronary artery bypass graft surgery or aortic valve replacement surgery with extracorporeal circulation
  • must be over 18 years of age
  • must be able to read and understand the consent form in French
  • must be in sinus rhythm at inclusion time

Exclusion Criteria:

  • medical history of type 1 diabetes
  • medical history of sustained atrial arrhythmia
  • pregnancy
  • class III anti-arhythmic drug

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: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obese patients
patients with BMI > 30
Other: functional tissu atrial analysis
no obese patients
norma weight patient (BMI<25) overweight patients ( 25< BMI >30)
Other: functional tissu atrial analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrinsic myocardial contractile force
Time Frame: the day of cardiac surgery
twitch force developed by atrial trabeculae assessed in isometric conditions in atrial samples
the day of cardiac surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sarcomere sensitivity to calcium
Time Frame: the day of cardiac surgery
force-calcium concentration relation assessed on permeabilized atrial fibers
the day of cardiac surgery
Mitochondrial function
Time Frame: the day of cardiac surgery
assesment of mitochondrial respiration and calcium retention capacity by oxygraphic measurement in saponin-permeabilized atrial fibers
the day of cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: David Montaigne, MD, University Hospital, Lille

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)

June 3, 2013

Primary Completion (Actual)

January 19, 2017

Study Completion (Actual)

January 19, 2017

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012_09
  • 2012-A01605-38 (Other Identifier: ID-RCB number, ANSM)

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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