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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02216-33 | Registry Identifier | ID-RCB |
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The MeDIAGSTOLE project aims to develop diagnostic tools for heart failure with preserved ejection fraction (IC / FEp), a pathology that is difficult to diagnose and to manage clinically in the absence of targeted treatment . The IC / FEp concerns the elderly population with comorbidities such as hypertension, obesity, anemia and atrial fibrillation. In the absence of specific biomarkers, clinical diagnosis is based on serum markers of heart failure with reduced ejection fraction (IC / FEr). The identification of new biomarkers, genetic and / or cellular, specific for IC / FEp would be an important innovation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preserved ejection fraction | Patients with a preserved ejection fraction (HF / FEp) |
| |
| reduced ejection fraction | Patients with a reduced ejection fraction (HF / FEr) |
| |
| without heart failure | Patient without heart failure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling, questionnaires and specific exams | Other | Patients will have additionnal blood samples, answer to self-questionnaires and will performed an electrocardiogram and an echocardiography if not performed in routine care. |
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic power of a multi-marker approach (progenitor cells) | to estimate the diagnostic power of a the multi-marker approach combining 5 circulating biomarkers (biochemical and cellular) in IC / FEp versus heart failure with reduced ejection fraction (IC / FEr) : first biomarker (cellular) : progenitor cells Value in µL. | At 12 months |
| diagnostic power of a multi-marker approach (monocytes) | to estimate the diagnostic power of a the multi-marker approach combining 5 circulating biomarkers (biochemical and cellular) in IC / FEp versus heart failure with reduced ejection fraction (IC / FEr) : second biomarker (cellular) : monocytes Value in µL. | At 12 months |
| diagnostic power of a multi-marker approach (NT-proBNP) | to estimate the diagnostic power of a the multi-marker approach combining 5 circulating biomarkers (biochemical and cellular) in IC / FEp versus heart failure with reduced ejection fraction (IC / FEr) : third biomarker (biochemical) : NT-proBNP Value in ng/L. | At 12 months |
| diagnostic power of a multi-marker approach (sST2) | to estimate the diagnostic power of a the multi-marker approach combining 5 circulating biomarkers (biochemical and cellular) in IC / FEp versus heart failure with reduced ejection fraction (IC / FEr) : fourth biomarker (biochemical) : sST2 Value in ng/L. | At 12 months |
| diagnostic power of a multi-marker approach (PIIINP) | to estimate the diagnostic power of a the multi-marker approach combining 5 circulating biomarkers (biochemical and cellular) in IC / FEp versus heart failure with reduced ejection fraction (IC / FEr) : fifth biomarker (biochemical) : PIIINP Value in ng/L. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in gene expression | Carry out a molecular approach based on high throughput genetic sequencing. This will make it possible to determine the variations in gene expression : coding or not coding RNA. | At 12 months |
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Inclusion Criteria group 1 (ejection fraction ≥ 50%) :
Inclusion Criteria group 2 (ejection fraction < 50%) :
Inclusion Criteria group 3 (without heart failure) :
Exclusion Criteria for all groups:
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The inclusions will be done in the Cardiology department (Prof. F. Roubille) by the team of cardiologists trained in the study. Patients eligible for the study will be selected either from already hospitalized patients or from outside patients during the weekly consultation.
In order to be representative of the population of interest (patients followed in cardiology consultation) and to limit inclusion bias, the inclusions will be exhaustive and consecutive. A collection of reasons for refusal will be made for the construction of the study flow chart.
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| Name | Affiliation | Role |
|---|---|---|
| Sylvain Aguilhon, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Montpellier | 34090 | France |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |