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Completed

NCT Number: NCT04699890

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Montpellier

Montpellier, 34090, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. Variation in gene expression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: MeDIAGSTOLE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2021
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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