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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Blood sampling, questionnaires and specific exams

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Sylvain Aguilhon, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: biomarkers; diastolic dysfunction; Heart Failure (HF); progenitors cells
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires; Blood Specimen Collection
• Other Study ID Numbers: RECHMPL18_0466; 2020-A02216-33 (Registry Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No