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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384252
• Other study ID #: 2012_09
• Secondary ID: 2012-A01605-38
• Status: Completed
• Start date: June 3, 2013
• Est. completion date: January 19, 2017

Study information

• Verified date: July 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 19, 2017
• Est. primary completion date: January 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Obesity

Intervention

Other:
• functional tissu atrial analysis

Locations

Country	Name	City	State
France	Hôpital Cardiologique - EFCV - CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrinsic myocardial contractile force	twitch force developed by atrial trabeculae assessed in isometric conditions in atrial samples	the day of cardiac surgery
Secondary	sarcomere sensitivity to calcium	force-calcium concentration relation assessed on permeabilized atrial fibers	the day of cardiac surgery
Secondary	Mitochondrial function	assesment of mitochondrial respiration and calcium retention capacity by oxygraphic measurement in saponin-permeabilized atrial fibers	the day of cardiac surgery