The Metabolic Road to Diastolic Heart Failure (MEDIA) - Diastolic Heart Failure Study (DHF)
- Conditions
- Heart Failure with Normal Ejection FractionHeart Failure with Preserved Ejection Fraction10019280
- Registration Number
- NL-OMON39049
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 225
Patients 18 years of age or older
Able and willing to provide freely given written informed consent including analysis of genomics.
Signs or symptoms of Heart Failure, preserved LVEF (>50%) and evidence of diastolic dysfunction: ;The ratio of early mitral valve flow velocity (E) and early TD lengthening velocity (E*), E/E*>15.
In the case that E/E* ratio is only suggestive of diastolic LV dysfunction (15>E/E*>8), additional non-invasive measures are required for the diagnosis of LV diastolic dysfunction. These consist of:
• Plasma levels of natriuretic peptides (NT-proBNP> 220 pg/mL or BNP > 200 pg/mL) OR
• Echo - blood flow Doppler of mitral valve - ratio of early (E) to late (A) mitral valve flow velocity (E/A) <0.5 and deceleration time (DC) > 280 ms OR
• Echo- blood flow Doppler of pulmonary veins - duration of reverse pulmonary vein atrial systole flow (Ard) and duration of mitral valve atrial wave flow (Ad) (Ard-Ad >30ms) OF
• Echo measure of left atrial volume index (LAVI) > 34 mL/m2 OR
• Echo measure of left ventricular max index (LVMI)> 109 g/m2 for women; 132 g/m2 for men) OR
• Electrocardiografic evidence of atrial fibrillation
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
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the specificity and the sensitivity of biomarkers for the<br /><br>diagnosis of DHF.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The prognostic power of biomarkers relative to all-cause death, cardiovascular<br /><br>hospitalization, death or cardiovascular hospitalization.</p><br>