Diastolic Heart FailureMEDIA-DHFNCT02446327
The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study
A study testing Blood sampling for biomarker assessment in people with Diastolic Heart Failure, run by Central Hospital, Nancy, France.
Trial summary
The main objective is to replicate the validation of omics biomarkers of left ventricular diastolic dysfunction in patients with metabolic syndrome. The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625 patients were enrolled in Europe and 47 in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- Blood sampling for biomarker assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Signs or symptoms of HF
- Able and willing to provide freely given written informed consent including analysis of genomics
Who cannot join
- Patients with acute myocardial infarction
- Recent trauma or surgery (< 3 months)
- Hemodynamically significant valvular disease
- Serious cerebrovascular disease or stroke in the last 3 months
- Chronic dialysis
- Chronic liver disease
Show all 10Show fewer
- Chronic infectious (bacterial or viral) disease
- Any malignant concomitant diseases or a malignant disease in the last 5 years
- Systemic inflammatory diseases, such as autoimmune diseases, connective tissue diseases or collagenoses
- Pregnant women
About this study
Official title: The Metabolic Road to Diastolic Heart Failure : Diastolic Heart Failure Study (MEDIA-DHF)
The main objective is to replicate the validation of omics biomarkers of left ventricular diastolic dysfunction in patients with metabolic syndrome.
The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625 patients were enrolled in Europe and 47 in France.
- Conditions
- Diastolic Heart Failure
- Being tested
- Blood sampling for biomarker assessment
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for biomarker assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Diastolic heart failure cohort | Other | This is a prospective cohort of patients with diastolic heart failure. Blood sampling for biomarker assessment Receives: Other: Blood sampling for biomarker assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Hospitalizations or Cardiovascular Death
Measured: 12 months
Secondary outcomes (6)
Cardiovascular Hospitalizations
Measured: 3 months, 6 months, 12 months
Heart Failure Hospitalizations
Measured: 3 months, 6 months, 12 months
Other cardiovascular hospitalizations
Measured: 3 months, 6 months, 12 months
Non cardiovascular hospitalizations
Measured: 3 months, 6 months, 12 months
Cardiovascular Death
Measured: 3 months, 6 months, 12 months
Non cardiovascular Death
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446327
- Sponsor's protocol ID
- 2012-A00097-36
- Acronym
- MEDIA-DHF
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2015
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Stienen S, Ferreira JP, Kobayashi M, Preud'homme G, Dobre D, Machu JL, Duarte K, Bresso E, Devignes MD, Lopez N, Girerd N, Aakhus S, Ambrosio G, Brunner-La Rocca HP, Fontes-Carvalho R, Fraser AG, van Heerebeek L, Heymans S, de Keulenaer G, Marino P, McDonald K, Mebazaa A, Papp Z, Raddino R, Tschope C, Paulus WJ, Zannad F, Rossignol P. Enhanced clinical phenotyping by mechanistic bioprofiling in heart failure with preserved ejection fraction: insights from the MEDIA-DHF study (The Metabolic Road to Diastolic Heart Failure). Biomarkers. 2020 Mar;25(2):201-211. doi: 10.1080/1354750X.2020.1727015. Epub 2020 Feb 16.
PubMed 32063068Lagrange J, Jahangiri M PhD, Baudry G, Mercier N, Monzo L, Lamiral Z, Duarte K, Ter Maaten JM, Zannad F, Voors AA, Girerd N. Association Between Endothelial Alterations, Cardiac Function, and Outcomes From Health to Heart Failure: Insight From the STANISLAS, MEDIA-DHF, and BIOSTAT-CHF Cohorts. J Am Heart Assoc. 2025 Jun 3;14(11):e040179. doi: 10.1161/JAHA.124.040179. Epub 2025 May 29.
PubMed 40439171Stienen S, Ferreira JP, Kobayashi M, Preud'homme G, Dobre D, Machu JL, Duarte K, Bresso E, Devignes MD, Andres NL, Girerd N, Aakhus S, Ambrosio G, Rocca HB, Fontes-Carvalho R, Fraser AG, van Heerebeek L, de Keulenaer G, Marino P, McDonald K, Mebazaa A, Papp Z, Raddino R, Tschope C, Paulus WJ, Zannad F, Rossignol P. Sex differences in circulating proteins in heart failure with preserved ejection fraction. Biol Sex Differ. 2020 Aug 24;11(1):47. doi: 10.1186/s13293-020-00322-7.
PubMed 32831121
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Road to Diastolic Heart Failure : Diastolic Heart Failure Study (MEDIA-DHF)
- ClinicalTrials.gov ID
- NCT02446327
- Acronym / sponsor ID
- MEDIA-DHF / 2012-A00097-36
- Conditions
- Diastolic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 May 2015 (estimated)
- 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 main objective is to replicate the validation of omics biomarkers of left ventricular diastolic dysfunction in patients with metabolic syndrome.
The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625 patients were enrolled in Europe and 47 in France.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diastolic heart failure cohort | Other | Other: Blood sampling for biomarker assessmentThis is a prospective cohort of patients with diastolic heart failure. Blood sampling for biomarker assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
- Signs or symptoms of HF
- Able and willing to provide freely given written informed consent including analysis of genomics
Key exclusion criteria (10 listed)
- Patients with acute myocardial infarction
- Recent trauma or surgery (< 3 months)
- Hemodynamically significant valvular disease
- Serious cerebrovascular disease or stroke in the last 3 months
- Chronic dialysis
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 for biomarker assessment | Other | Diastolic heart failure cohort |
Primary outcome
Cardiovascular Hospitalizations or Cardiovascular Death
Time frame: 12 months
6 secondary outcomes
Cardiovascular Hospitalizations
Time frame: 3 months, 6 months, 12 months
Heart Failure Hospitalizations
Time frame: 3 months, 6 months, 12 months
Other cardiovascular hospitalizations
Time frame: 3 months, 6 months, 12 months
Non cardiovascular hospitalizations
Time frame: 3 months, 6 months, 12 months
Cardiovascular Death
Time frame: 3 months, 6 months, 12 months
Non cardiovascular Death
Time frame: 3 months, 6 months, 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 25 Jun 2026.
- Results publication: PubMed 32063068Stienen S, Ferreira JP, Kobayashi M, Preud'homme G, Dobre D, Machu JL, Duarte K, Bresso E, Devignes MD, Lopez N, Girerd N, Aakhus S, Ambrosio G, Brunner-La Rocca HP, Fontes-Carvalho R, Fraser AG, van Heerebeek L, Heymans S, de Keulenaer G, Marino P, McDonald K, Mebazaa A, Papp Z, Raddino R, Tschope C, Paulus WJ, Zannad F, Rossignol P. Enhanced clinical phenotyping by mechanistic bioprofiling in heart failure with preserved ejection fraction: insights from the MEDIA-DHF study (The Metabolic Road to Diastolic Heart Failure). Biomarkers. 2020 Mar;25(2):201-211. doi: 10.1080/1354750X.2020.1727015. Epub 2020 Feb 16.
- Derived from this study: PubMed 40439171Lagrange J, Jahangiri M PhD, Baudry G, Mercier N, Monzo L, Lamiral Z, Duarte K, Ter Maaten JM, Zannad F, Voors AA, Girerd N. Association Between Endothelial Alterations, Cardiac Function, and Outcomes From Health to Heart Failure: Insight From the STANISLAS, MEDIA-DHF, and BIOSTAT-CHF Cohorts. J Am Heart Assoc. 2025 Jun 3;14(11):e040179. doi: 10.1161/JAHA.124.040179. Epub 2025 May 29.
- Derived from this study: PubMed 32831121Stienen S, Ferreira JP, Kobayashi M, Preud'homme G, Dobre D, Machu JL, Duarte K, Bresso E, Devignes MD, Andres NL, Girerd N, Aakhus S, Ambrosio G, Rocca HB, Fontes-Carvalho R, Fraser AG, van Heerebeek L, de Keulenaer G, Marino P, McDonald K, Mebazaa A, Papp Z, Raddino R, Tschope C, Paulus WJ, Zannad F, Rossignol P. Sex differences in circulating proteins in heart failure with preserved ejection fraction. Biol Sex Differ. 2020 Aug 24;11(1):47. doi: 10.1186/s13293-020-00322-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling for biomarker assessment in people with Diastolic Heart Failure, run by Central Hospital, Nancy, 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 3 inclusion and 10 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Cardiovascular Hospitalizations or Cardiovascular Death (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02446327, which also lists 3 linked publications.
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 25 Jun 2026.