This study will address the mechanisms of DHF by identifying the role of biomarkers in the process of neurohormonal activation, cytokine activation and oxidative stress, the role of biomarkers at myocardial level in the process of cardiomyocyte cell…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the specificity and the sensitivity of biomarkers for the
diagnosis of DHF.
Secondary outcome
The prognostic power of biomarkers relative to all-cause death, cardiovascular
hospitalization, death or cardiovascular hospitalization.
Background summary
Diastolic heart failure (DHF) accounts for more than 50% of all heart failure
cases and portrays a high risk of morbidity and mortality. Currently, the
diagnosis of DHF is based on signs or symptoms of heart failure, normal or
mildly abnormal left ventricular ejection fraction (LVEF) and evidence of
diastolic left ventricular (LV) dysfunction. (2). Contrary to their usefulness
for the diagnosis of symptomatic diastolic LV dysfunction, natriuretic peptides
are sub-optimal screening tests for pre-clinical diagnostic of LV dysfunction.
Thus, there is no single biomarker that can accurately predict the development
or validate the diagnosis of LV Diastolic Dysfunction.
Study objective
This study will address the mechanisms of DHF by identifying the role of
biomarkers in the process of neurohormonal activation, cytokine activation and
oxidative stress, the role of biomarkers at myocardial level in the process of
cardiomyocyte cell growth and extracellular matrix turnover as well as the role
of proteomic markers such as cardiomyocyte sarcomeric and cytoskeletical
proteins in the risk of developing these major disturbances.
Integrating all DHF patients into a single database and biobank is necessary to
achieve adequate DHF sample size, to guarantee uniform criteria for DHF
diagnosis and to have shared platform for biomarker analysis. Over time, this
database will be extended with novel biomarkers as well as novel imaging and
vascular function tests. Through these activities the DHF-Study will assemble a
comprehensive database and biobank of common and novel biomarkers, imaging and
vascular tests as well as clinical data relevant for DHF. This will contribute
to better diagnostic tools to identify subjects with DHF and to predict
prognosis.
Study design
At baseline, all major demographics, the medical history, use of medication and
the risk factors will be collected. After this, a physical examination, ECG and
echocardography are performed.
These tests are complemented by a routine bloodsample with testing for
lipid-profile, glucose and insulin, hemoglobin, BNP and NT-proBNP. A
supplementary bloodsample (50cc) and urinesample (10cc) are taken and
transferred to the Biobank at the Centre d-investigation clinique (CIC) in
Nancy (France). Samples are stored at the CIC until central analysis is
performed.
At 3, 6 an 12 months the patients are contacted by telephone and outcomes
(death (any cause), heart failure and other cardiovascular hospitalizations,
heart failure and other cardiovascular death) are assessed.
Study burden and risks
There is no additionale risk to the patient to take part in this study. The
single bloodsample can be taken as part as a routine bloodanalysis.
Van der Boechorststraat 7
Amsterdam 1081BT
NL
Van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38526.029.11 |