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Clinical Trials/NCT04699890
NCT04699890
Completed
Not Applicable

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

University Hospital, Montpellier1 site in 1 country91 target enrollmentJanuary 11, 2022
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University Hospital, Montpellier
Enrollment
91
Locations
1
Primary Endpoint
diagnostic power of a multi-marker approach (progenitor cells)
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 11, 2022
End Date
January 31, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

diagnostic power of a multi-marker approach (progenitor cells)

Time Frame: At 12 months

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.

diagnostic power of a multi-marker approach (sST2)

Time Frame: At 12 months

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.

diagnostic power of a multi-marker approach (monocytes)

Time Frame: At 12 months

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.

diagnostic power of a multi-marker approach (NT-proBNP)

Time Frame: At 12 months

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.

diagnostic power of a multi-marker approach (PIIINP)

Time Frame: At 12 months

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.

Secondary Outcomes

  • Variation in gene expression(At 12 months)

Study Sites (1)

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