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

Completed

• Conditions: Heart Failure
• Interventions: Other: Blood sampling, questionnaires and specific exams

• Registration Number: NCT04699890
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Study Start: 2022-01-11
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
reduced ejection fraction	Blood sampling, questionnaires and specific exams	Patients with a reduced ejection fraction (HF / FEr)
preserved ejection fraction	Blood sampling, questionnaires and specific exams	Patients with a preserved ejection fraction (HF / FEp)
without heart failure	Blood sampling, questionnaires and specific exams	Patient without heart failure

Primary Outcome Measures

Name	Time	Method
diagnostic power of a multi-marker approach (progenitor cells)	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Variation in gene expression	At 12 months	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.

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, France