Heart FailureMeDIAGSTOLENCT04699890
Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction
An observational study of Heart Failure, run by University Hospital, Montpellier at 1 site in France.
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 . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Blood sampling, questionnaires and specific exams
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2022to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The inclusions will be done in the Cardiology department (Prof. F. Roubille) by the team of cardiologists trained in the study. Patients eligible for the study will be selected either from already hospitalized patients or from outside patients during the weekly consultation. In order to be representative of the population of interest (patients followed in cardiology consultation) and to limit inclusion bias, the inclusions will be exhaustive and consecutive. A collection of reasons for refusal will be made for the construction of the study flow chart.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Blood sampling, questionnaires and specific exams
- Keywords
- Heart Failure (HF), progenitors cells, biomarkers, diastolic dysfunction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling, questionnaires and specific examsOther
Patients will have additionnal blood samples, answer to self-questionnaires and will performed an electrocardiogram and an echocardiography if not performed in routine care.
| Study group | Role | What they receive |
|---|---|---|
| preserved ejection fraction | Patients with a preserved ejection fraction (HF / FEp) Receives: Other: Blood sampling, questionnaires and specific exams | |
| reduced ejection fraction | Patients with a reduced ejection fraction (HF / FEr) Receives: Other: Blood sampling, questionnaires and specific exams | |
| without heart failure | Patient without heart failure Receives: Other: Blood sampling, questionnaires and specific exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months
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.
Measured: At 12 months
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.
Measured: At 12 months
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.
Measured: At 12 months
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.
Measured: At 12 months
Secondary outcomes (1)
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.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start11 Jan 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Aguilhon, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699890
- Sponsor's protocol ID
- RECHMPL18_0466
- Other IDs
- 2020-A02216-33
- Acronym
- MeDIAGSTOLE
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2020
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04699890
- Acronym / sponsor ID
- MeDIAGSTOLE / RECHMPL18_0466
- Conditions
- Heart Failure
- Keywords
- Heart Failure (HF), progenitors cells, biomarkers, diastolic dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preserved ejection fraction | – | Other: Blood sampling, questionnaires and specific examsPatients with a preserved ejection fraction (HF / FEp) |
| reduced ejection fraction | – | Other: Blood sampling, questionnaires and specific examsPatients with a reduced ejection fraction (HF / FEr) |
| without heart failure | – | Other: Blood sampling, questionnaires and specific examsPatient without heart failure |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The inclusions will be done in the Cardiology department (Prof. F. Roubille) by the team of cardiologists trained in the study. Patients eligible for the study will be selected either from already hospitalized patients or from outside patients during the weekly consultation. In order to be representative of the population of interest (patients followed in cardiology consultation) and to limit inclusion bias, the inclusions will be exhaustive and consecutive. A collection of reasons for refusal will be made for the construction of the study flow chart.
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling, questionnaires and specific examsPatients will have additionnal blood samples, answer to self-questionnaires and will performed an electrocardiogram and an echocardiography if not performed in routine care. | Other | preserved ejection fraction, reduced ejection fraction, without heart failure |
Primary outcome
diagnostic power of a multi-marker approach (progenitor cells)
Time frame: At 12 months
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.
diagnostic power of a multi-marker approach (monocytes)
Time frame: At 12 months
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.
diagnostic power of a multi-marker approach (NT-proBNP)
Time frame: At 12 months
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.
diagnostic power of a multi-marker approach (sST2)
Time frame: At 12 months
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.
diagnostic power of a multi-marker approach (PIIINP)
Time frame: At 12 months
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.
1 secondary outcome
Variation in gene expression
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Aguilhon, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic power of a multi-marker approach (progenitor cells) (time frame: At 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.