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

NCT04699890 | Completed

• 2 other identifiers: RECHMPL18_04662020-A02216-33
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure (HF); progenitors cells; biomarkers; diastolic dysfunction

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Variation in gene expression

  At 12 months

Study Arms (3)

preserved ejection fraction

Patients with a preserved ejection fraction (HF / FEp)

Other: Blood sampling, questionnaires and specific exams

reduced ejection fraction

Patients with a reduced ejection fraction (HF / FEr)

Other: Blood sampling, questionnaires and specific exams

without heart failure

Patient without heart failure

Other: Blood sampling, questionnaires and specific exams

Interventions

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.

preserved ejection fraction; reduced ejection fraction; without heart failure

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.
• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sylvain Aguilhon, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: January 7, 2021
• Study Start: January 11, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-02

Locations

FR (1)