Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction

Study Overview
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Brief Summary
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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.

Official Title
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Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Blood sampling, questionnaires and specific exams


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria group 1 (ejection fraction ≥ 50%) : Age > or = 65, heart failure (NT-proBNP ≥ 450 pg/mL during hospitalization or follow-up) echocardiography showing an ejection fraction ≥ 50%, patients already hospitalized and followed in cardiology consultation, patients agreeing to sign informed consent, patient affiliated to french health care system. Inclusion Criteria group 2 (ejection fraction < 50%) : Age > or = 65, heart failure (NT-proBNP ≥ 450 pg/mL during hospitalization or follow-up) echocardiography showing an ejection fraction < 50%, patients already hospitalized and followed in cardiology consultation, patients agreeing to sign informed consent, patient affiliated to french health care system. Inclusion Criteria group 3 (without heart failure) : Age > or = 65, patients already hospitalized and followed in cardiology consultation for one of the following pathology : stable coronaropathy without heart failure, arterial hypertension without heart failure, auricular fibrilation without heart failure patients agreeing to sign informed consent, patient affiliated to french health care system. Exclusion Criteria for all groups: Hemodynamic instability (cardiogenic shock), any condition leading to a prognosis of less than 7 days, Known hepatocellular insufficiency, or known hepatic cirrhosis ASAT / ALAT> 10N excluding cardiac cause Any conditions that may put the patient at risk or increase the risk of non-compliance with the protocol or lost to follow-up according to the opinion of the investigator Patient under legal protection, under guardianship or under curatorship Inability to give the subject informed information Pregnant or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| preserved ejection fraction<br>Patients with a preserved ejection fraction (HF / FEp) | Other: Blood sampling, questionnaires and specific exams<br>* Patients will have additionnal blood samples, answer to self-questionnaires and will performed an electrocardiogram and an echocardiography if not performed in routine care.<br>|
| reduced ejection fraction<br>Patients with a reduced ejection fraction (HF / FEr) | Other: Blood sampling, questionnaires and specific exams<br>* Patients will have additionnal blood samples, answer to self-questionnaires and will performed an electrocardiogram and an echocardiography if not performed in routine care.<br>|
| without heart failure<br>Patient without heart failure | Other: Blood sampling, questionnaires and specific exams<br>* Patients will have additionnal blood samples, answer to self-questionnaires and will performed an electrocardiogram and an echocardiography if not performed in routine care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure (HF), progenitors cells, biomarkers, diastolic dysfunction