Type II DiabetesDIAPASONNCT01862237
Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.
A study testing Intervention in people with Type II Diabetes, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jan 2017
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 years
- Arm 1: Treated Type II diabetes, Arm 2: absence of type II diabetes
- Aortic valve stenosis
- LVEF > 50% with no kinetic abnormalities
- Non significant obstructive coronary artery disease
- Absence of gadolinium enhanced MRI contraindications
- Informed consent signed
- Patient affiliated to the French Social Security.
Who cannot join
- Chronic arrhythmia or absence of sinus rhythm
- Past history of cardiomyopathy or coronary insufficiency
- Significant coronaropathy seen during the coronary angiography with >50% degree stenosis prior to aortic valve replacement
- Hemodynamically significant valvular dysfunction other than aortic stenosis (grade 2 mitral or aortic insufficiency, mitral valve stenosis < 1.5 cm2)
- Systemic chronic inflammatory disease leading to cardiac injury (scleroderma)
- Renal insufficiency (clearance < 30 ml/min)
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- Insufficient transthoracic echocardiography echogenicity
- Type I diabetes mellitus
- Uncontrolled hypertension (> 180/100 mm Hg)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital Louis Pradel
Lyon
Hélène THIBAULT, 4 72 35 73 32 ext. +33, helene.thibault@chu-lyon.fr
Hélène THIBAULT
About this study
Official title: Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.
The main objective is to compare the reverse left ventricular remodeling between patients with type II diabetes and case-control patients without diabetes at one(1) year after surgical aortic valve replacement.
Read more
The secondary objectives are :
- assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis,
- assess the predictive value of myocardial fibrosis and other LV characteristics present prior to aortic valve surgery on the LV reverse remodeling and their influence on cardiovascular events at one (1) year after surgery,
- assess the influence of type II diabetes on cardiovascular morbidity and mortality post aortic valve surgery.
The investigators main hypothesis is that patients with type II diabetes and aortic valve stenosis requiring aortic valve replacement have poorer LV function and less favorable post surgery clinical outcomes than patients without type II diabetes.
- Conditions
- Type II Diabetes
- Being tested
- Intervention
- Keywords
- Type II diabetes, aortic valve stenosis, left ventricular remodeling, aortic valve replacement surgery
- Medical subject headings
- Diabetes Mellitus, Type 2, Aortic Valve Stenosis, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
- blood collection
- Completion of a pre-operative cardiac MRI.
- Completion of a coronary angiography examination
- Completion during the surgery d'une myocardial biopsy,
- Aortic echocardiographic follow-up (including post-operative ultrasound and ultrasound at 1 year
- Completion of a cardiac MRI 1 year after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type II diabetes | Experimental | Type II diabetes patients with aortic valve stenosis referred for aortic valve replacement. Receives: Other: Intervention |
| Patients without type II diabetes | Experimental | No type II diabetes patients with aortic valve stenosis referred for aortic valve replacement. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Mass measured by echocardiography
Measured: Primary outcome is assessed at one year 1 year after aortic valve replacement.
Secondary outcomes (4)
cardiovascular events (cardiac mortality, heart failure, atrial or ventricular rhythm abnormalities) and clinical improvement (NYHA class, 6-minute walk test).
Measured: 1 year after aortic valve replacement.
Measurement of BNP (Brain Natriuretic Peptide).
Measured: 1 year after aortic valve replacement.
Echocardiographic parameters.
Left Ventricular Ejection Fraction, Systolic Longitudinal Strain, Systolic Circumferential Strain, Systolic Radial Strain, Diameters, wall thickness.
Measured: 1 year after aortic valve replacement.
Magnetic Resonance Imaging (MRI) parameters.
LV mass, volumes, ejection fraction, replacement fibrosis mass on delayed enhanced studies, and interstitial fibrosis quantification (T1 mapping studies).
Measured: 1 year after aortic valve replacement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862237
- Sponsor's protocol ID
- 2011.699
- Acronym
- DIAPASON
- Status last verified
- Aug 2014
- First submitted
- 22 May 2013
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cherpaz M, Meugnier E, Seillier G, Pozzi M, Pierrard R, Leboube S, Farhat F, Vola M, Obadia JF, Amaz C, Chalabreysse L, May C, Chanon S, Brun C, Givre L, Bidaux G, Mewton N, Derumeaux G, Bergerot C, Paillard M, Thibault H. Myocardial transcriptomic analysis of diabetic patients with aortic stenosis: key role for mitochondrial calcium signaling. Cardiovasc Diabetol. 2024 Jul 8;23(1):239. doi: 10.1186/s12933-024-02329-5.
PubMed 38978010
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?
- ClinicalTrials.gov ID
- NCT01862237
- Acronym / sponsor ID
- DIAPASON / 2011.699
- Conditions
- Type II Diabetes
- Keywords
- Type II diabetes, aortic valve stenosis, left ventricular remodeling, aortic valve replacement surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 24 May 2013 (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.
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.
The main objective is to compare the reverse left ventricular remodeling between patients with type II diabetes and case-control patients without diabetes at one(1) year after surgical aortic valve replacement.
The secondary objectives are :
- assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis,
- assess the predictive value of myocardial fibrosis and other LV characteristics present prior to aortic valve surgery on the LV reverse remodeling and their influence on cardiovascular events at one (1) year after surgery,
- assess the influence of type II diabetes on cardiovascular morbidity and mortality post aortic valve surgery.
The investigators main hypothesis is that patients with type II diabetes and aortic valve stenosis requiring aortic valve replacement have poorer LV function and less favorable post surgery clinical outcomes than patients without type II diabetes.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type II diabetes | Experimental | Other: InterventionType II diabetes patients with aortic valve stenosis referred for aortic valve replacement. |
| Patients without type II diabetes | Experimental | Other: InterventionNo type II diabetes patients with aortic valve stenosis referred for aortic valve replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Arm 1: Treated Type II diabetes, Arm 2: absence of type II diabetes
- Aortic valve stenosis
- LVEF > 50% with no kinetic abnormalities
- Non significant obstructive coronary artery disease
Key exclusion criteria (9 listed)
- Chronic arrhythmia or absence of sinus rhythm
- Past history of cardiomyopathy or coronary insufficiency
- Significant coronaropathy seen during the coronary angiography with >50% degree stenosis prior to aortic valve replacement
- Hemodynamically significant valvular dysfunction other than aortic stenosis (grade 2 mitral or aortic insufficiency, mitral valve stenosis < 1.5 cm2)
- Systemic chronic inflammatory disease leading to cardiac injury (scleroderma)
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 |
|---|---|---|
| Intervention* blood collection * Completion of a pre-operative cardiac MRI. * Completion of a coronary angiography examination * Completion during the surgery d'une myocardial biopsy, * Aortic echocardiographic follow-up (including post-operative ultrasound and ultrasound at 1 year * Completion of a cardiac MRI 1 year after surgery. | Other | Patients with type II diabetes, Patients without type II diabetes |
Primary outcome
Left Ventricular Mass measured by echocardiography
Time frame: Primary outcome is assessed at one year 1 year after aortic valve replacement.
4 secondary outcomes
cardiovascular events (cardiac mortality, heart failure, atrial or ventricular rhythm abnormalities) and clinical improvement (NYHA class, 6-minute walk test).
Time frame: 1 year after aortic valve replacement.
Measurement of BNP (Brain Natriuretic Peptide).
Time frame: 1 year after aortic valve replacement.
Echocardiographic parameters.
Time frame: 1 year after aortic valve replacement.
Magnetic Resonance Imaging (MRI) parameters.
Time frame: 1 year after aortic valve replacement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Derived from this study: PubMed 38978010Cherpaz M, Meugnier E, Seillier G, Pozzi M, Pierrard R, Leboube S, Farhat F, Vola M, Obadia JF, Amaz C, Chalabreysse L, May C, Chanon S, Brun C, Givre L, Bidaux G, Mewton N, Derumeaux G, Bergerot C, Paillard M, Thibault H. Myocardial transcriptomic analysis of diabetic patients with aortic stenosis: key role for mitochondrial calcium signaling. Cardiovasc Diabetol. 2024 Jul 8;23(1):239. doi: 10.1186/s12933-024-02329-5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Type II Diabetes, run by Hospices Civils de Lyon 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 8 inclusion and 9 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 29 Aug 2014. 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 Hélène THIBAULT (4 72 35 73 32 ext. +33, helene.thibault@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Mass measured by echocardiography (time frame: Primary outcome is assessed at one year 1 year after aortic valve replacement.). 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 NCT01862237, 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 29 Aug 2014.