search
Back to results

The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study (MEDIA-DHF)

Primary Purpose

Diastolic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood sampling for biomarker assessment
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diastolic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Diastolic heart failure cohort

    Arm Description

    This is a prospective cohort of patients with diastolic heart failure. Blood sampling for biomarker assessment

    Outcomes

    Primary Outcome Measures

    Cardiovascular Hospitalizations or Cardiovascular Death

    Secondary Outcome Measures

    Cardiovascular Hospitalizations
    Heart Failure Hospitalizations
    Other cardiovascular hospitalizations
    Non cardiovascular hospitalizations
    Cardiovascular Death
    Non cardiovascular Death

    Full Information

    First Posted
    April 14, 2015
    Last Updated
    May 13, 2015
    Sponsor
    Central Hospital, Nancy, France
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02446327
    Brief Title
    The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study
    Acronym
    MEDIA-DHF
    Official Title
    The Metabolic Road to Diastolic Heart Failure : Diastolic Heart Failure Study (MEDIA-DHF)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diastolic Heart Failure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diastolic heart failure cohort
    Arm Type
    Other
    Arm Description
    This is a prospective cohort of patients with diastolic heart failure. Blood sampling for biomarker assessment
    Intervention Type
    Other
    Intervention Name(s)
    Blood sampling for biomarker assessment
    Primary Outcome Measure Information:
    Title
    Cardiovascular Hospitalizations or Cardiovascular Death
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Cardiovascular Hospitalizations
    Time Frame
    3 months, 6 months, 12 months
    Title
    Heart Failure Hospitalizations
    Time Frame
    3 months, 6 months, 12 months
    Title
    Other cardiovascular hospitalizations
    Time Frame
    3 months, 6 months, 12 months
    Title
    Non cardiovascular hospitalizations
    Time Frame
    3 months, 6 months, 12 months
    Title
    Cardiovascular Death
    Time Frame
    3 months, 6 months, 12 months
    Title
    Non cardiovascular Death
    Time Frame
    3 months, 6 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32831121
    Citation
    Stienen 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.
    Results Reference
    derived

    Learn more about this trial

    The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study

    We'll reach out to this number within 24 hrs