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

NCT ID: NCT04699890

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-11

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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preserved ejection fraction

Patients with a preserved ejection fraction (HF / FEp)

Blood sampling, questionnaires and specific exams

Intervention Type 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.

reduced ejection fraction

Patients with a reduced ejection fraction (HF / FEr)

Blood sampling, questionnaires and specific exams

Intervention Type 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.

without heart failure

Patient without heart failure

Blood sampling, questionnaires and specific exams

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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.


* 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

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvain Aguilhon, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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CHU Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2020-A02216-33

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL18_0466

Identifier Type: -

Identifier Source: org_study_id

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