Clinical trial NCT04699890: Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction
Official title: Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure (HF)
progenitors cells
biomarkers
diastolic dysfunction
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 91
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: diagnostic power of a multi-marker approach (progenitor cells)
timeFrame: At 12 months
measure: diagnostic power of a multi-marker approach (monocytes)
timeFrame: At 12 months
measure: diagnostic power of a multi-marker approach (NT-proBNP)
timeFrame: At 12 months
measure: diagnostic power of a multi-marker approach (sST2)
timeFrame: At 12 months
measure: diagnostic power of a multi-marker approach (PIIINP)
timeFrame: At 12 months
Secondary outcomes:
measure: Variation in gene expression
timeFrame: At 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Sylvain Aguilhon, MD
role: PRINCIPAL_INVESTIGATOR
References: