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

Completed
Conditions
Heart Failure with Normal Ejection Fraction
Heart Failure with Preserved Ejection Fraction
10019280
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
Inclusion Criteria

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

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
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To determine the specificity and the sensitivity of biomarkers for the<br /><br>diagnosis of DHF.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The prognostic power of biomarkers relative to all-cause death, cardiovascular<br /><br>hospitalization, death or cardiovascular hospitalization.</p><br>
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