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

May 13, 2015 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diastolic heart failure cohort
This is a prospective cohort of patients with diastolic heart failure. Blood sampling for biomarker assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular Hospitalizations or Cardiovascular Death
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular Hospitalizations
Time Frame: 3 months, 6 months, 12 months
3 months, 6 months, 12 months
Heart Failure Hospitalizations
Time Frame: 3 months, 6 months, 12 months
3 months, 6 months, 12 months
Other cardiovascular hospitalizations
Time Frame: 3 months, 6 months, 12 months
3 months, 6 months, 12 months
Non cardiovascular hospitalizations
Time Frame: 3 months, 6 months, 12 months
3 months, 6 months, 12 months
Cardiovascular Death
Time Frame: 3 months, 6 months, 12 months
3 months, 6 months, 12 months
Non cardiovascular Death
Time Frame: 3 months, 6 months, 12 months
3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-A00097-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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