- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02446327
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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