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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Heart Failure

Treatments

Other: Blood sampling, questionnaires and specific exams

Study type

Observational

Funder types

Other

Identifiers

NCT04699890
RECHMPL18_0466
2020-A02216-33 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

91 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

91 participants in 3 patient groups

preserved ejection fraction
Description:
Patients with a preserved ejection fraction (HF / FEp)
Treatment:
Other: Blood sampling, questionnaires and specific exams
reduced ejection fraction
Description:
Patients with a reduced ejection fraction (HF / FEr)
Treatment:
Other: Blood sampling, questionnaires and specific exams
without heart failure
Description:
Patient without heart failure
Treatment:
Other: Blood sampling, questionnaires and specific exams

Trial contacts and locations

1

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Central trial contact

Sylvain Aguilhon, MD

Data sourced from clinicaltrials.gov

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