Diastolic Heart Failure
Conditions
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.
Interventions
OTHERBlood sampling for biomarker assessment
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular Hospitalizations or Cardiovascular Death | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular Hospitalizations | 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 Death | 3 months, 6 months, 12 months |
| Non cardiovascular Death | 3 months, 6 months, 12 months |
Outcome results
None listed