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

Heart Failure Clinical Trial

— MeDIAGSTOLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699890
• Other study ID #: UF7733
• Status: Recruiting
• Start date: January 11, 2022
• Est. completion date: January 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Montpellier
• Contact: Sylvain Aguilhon, MD
• Phone: +33788014858
• Email: s-aguilhon[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2025
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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