ObesityNCT02384252
Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction
An observational study of Obesity and Heart Failure, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Heart Failure
- What is being tested?
- functional tissu atrial analysis
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2013to 19 Jan 2017
- 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: consecutive patients undergoing coronary artery bypass graft surgery or aortic valve replacement surgery with extracorporeal circulation
Who may be able to join
- 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
Who cannot join
- medical history of type 1 diabetes
- medical history of sustained atrial arrhythmia
- pregnancy
- class III anti-arhythmic drug
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Heart Failure
- Being tested
- functional tissu atrial analysis
- Keywords
- obese cardiomyopathy, mitochondria, contractile dysfunction
- Medical subject headings
- Obesity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional tissu atrial analysisOther
| Study group | Role | What they receive |
|---|---|---|
| obese patients | patients with BMI > 30 Receives: Other: functional tissu atrial analysis | |
| no obese patients | norma weight patient (BMI<25) overweight patients ( 25< BMI >30) Receives: Other: functional tissu atrial analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrinsic myocardial contractile force
twitch force developed by atrial trabeculae assessed in isometric conditions in atrial samples
Measured: the day of cardiac surgery
Secondary outcomes (2)
sarcomere sensitivity to calcium
force-calcium concentration relation assessed on permeabilized atrial fibers
Measured: the day of cardiac surgery
Mitochondrial function
assesment of mitochondrial respiration and calcium retention capacity by oxygraphic measurement in saponin-permeabilized atrial fibers
Measured: the day of cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start3 Jun 2013
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Montaigne, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384252
- Sponsor's protocol ID
- 2012_09
- Other IDs
- 2012-A01605-38
- Status last verified
- Jul 2019
- First submitted
- 4 Mar 2015
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction
- ClinicalTrials.gov ID
- NCT02384252
- Acronym / sponsor ID
- 2012_09
- Conditions
- Obesity, Heart Failure
- Keywords
- obese cardiomyopathy, mitochondria, contractile dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Jun 2013 (actual)
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese patients | – | Other: functional tissu atrial analysispatients with BMI > 30 |
| no obese patients | – | Other: functional tissu atrial analysisnorma weight patient (BMI<25) overweight patients ( 25< BMI >30) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients undergoing coronary artery bypass graft surgery or aortic valve replacement surgery with extracorporeal circulation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- medical history of type 1 diabetes
- medical history of sustained atrial arrhythmia
- pregnancy
- class III anti-arhythmic drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional tissu atrial analysis | Other | no obese patients, obese patients |
Primary outcome
Intrinsic myocardial contractile force
Time frame: the day of cardiac surgery
twitch force developed by atrial trabeculae assessed in isometric conditions in atrial samples
2 secondary outcomes
sarcomere sensitivity to calcium
Time frame: the day of cardiac surgery
Mitochondrial function
Time frame: the day of cardiac surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Montaigne, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Heart Failure, run by University Hospital, Lille 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrinsic myocardial contractile force (time frame: the day of cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2019.