Status:
COMPLETED
Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Heart Failure
Eligibility:
All Genders
65+ years
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 absenc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04699890
Start Date
January 11 2022
End Date
January 31 2025
Last Update
September 30 2025
Active Locations (1)
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1
CHU Montpellier
Montpellier, France, 34090