The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study
Not Applicable
Completed
- Conditions
- Diastolic Heart Failure
- Registration Number
- NCT02446327
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Cardiovascular Hospitalizations or Cardiovascular Death 12 months
- Secondary Outcome Measures
Name Time Method Cardiovascular Death 3 months, 6 months, 12 months Non cardiovascular Death 3 months, 6 months, 12 months Heart Failure Hospitalizations 3 months, 6 months, 12 months Other cardiovascular hospitalizations 3 months, 6 months, 12 months Non cardiovascular hospitalizations 3 months, 6 months, 12 months Cardiovascular Hospitalizations 3 months, 6 months, 12 months