NCT04699890Completed
Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction
Source: ClinicalTrials.gov · Last updated 30 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 91 (actual)
- First submitted
- 21 Sept 2020
- Start date
- 11 Jan 2022
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Heart failure
- NCT number
- NCT04699890
What you commit to
- Study type: Observational
- Participants enrolled: 91
- From 11 Jan 2022 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Hemodynamic instability (cardiogenic shock),
- Patient under legal protection, under guardianship or under curatorship
- Inability to give the subject informed information
- Pregnant or breastfeeding woman
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.