Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction
2 other identifiers
observational
134
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2013
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2017
CompletedJuly 10, 2019
July 1, 2019
3.6 years
March 4, 2015
July 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intrinsic myocardial contractile force
twitch force developed by atrial trabeculae assessed in isometric conditions in atrial samples
the day of cardiac surgery
Secondary Outcomes (2)
sarcomere sensitivity to calcium
the day of cardiac surgery
Mitochondrial function
the day of cardiac surgery
Study Arms (2)
obese patients
patients with BMI \> 30
no obese patients
norma weight patient (BMI\<25) overweight patients ( 25\< BMI \>30)
Interventions
Eligibility Criteria
consecutive patients undergoing coronary artery bypass graft surgery or aortic valve replacement surgery with extracorporeal circulation
You may qualify if:
- 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
You may not qualify if:
- medical history of type 1 diabetes
- medical history of sustained atrial arrhythmia
- pregnancy
- class III anti-arhythmic drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Cardiologique - EFCV - CHRU
Lille, France
Biospecimen
Right atrial tissue obtained during cannulation of the right atrium in preparation for cardiac surgery with extracorporeal circulation.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Montaigne, MD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 10, 2015
Study Start
June 3, 2013
Primary Completion
January 19, 2017
Study Completion
January 19, 2017
Last Updated
July 10, 2019
Record last verified: 2019-07