Status:
UNKNOWN
Serum and Cellular Biomarkers for Aortic Valve Stenosis
Lead Sponsor:
National and Kapodistrian University of Athens
Collaborating Sponsors:
Naval Hospital of Athens
Biomedical Research Foundation of the Academy of Athens
Conditions:
Calcific Aortic Valve Disease
Aortic Valve Stenosis
Eligibility:
All Genders
60-87 years
Brief Summary
AthenaValve aims to develop and initial validate a novel serum diagnostic kit, for the assessment of severity and prognosis of progression of aortic valve stenosis (AS, a devastating disease without e...
Detailed Description
The deposition of calcium salts in the arterial wall and the heart valves is a commonly occurring phenomenon associated with increasing age and various pathological factors. A particular case is the c...
Eligibility Criteria
Inclusion
- Retrospective cohort: patients with severe aortic valve stenosis in echocardiography:
- • Vmax \> 4 m/sec and mean Gradient \>40 mmHg and/or Aortic Valve Area indexed (AVAi) \< 0.6 cm2/m2 and/or Velocity index \<0.25 whichever worse, with available complete past echocardiographic follow-up (\>2 past studies) indicating disease progression, by the same performing physician.
- Prospective cohort: patients with moderate aortic valve stenosis in echocardiography:
- Vmax 3-4 m/sec and mean Gradient 25-40 mmHg and/or AVAi 0.6-0.9 cm2/m2,
- Where inconsistent: Velocity index = 0.25-0.50.
- Technical details: Optimal doppler measurements obtained by the best feasible echocardiographic window (demonstrating at least 2 windows, where possible including right parasternal with or without pencil probe).
- Prospective Control group: patients at intermediate to high risk for CVD according to atherosclerotic risk factors assessment - Heart Score
Exclusion
- Echocardiographic Stroke Volume indexed (SVi) \<35 ml/m2
- Bicuspid aortic valve
- Stenosis of rheumatic etiology
- More than mild aortic valve regurgitation
- More than mild mitral valve regurgitation
- More than mild mitral stenosis
- Severe pulmonary hypertension
- Chronic ischemic heart failure with Ejection Fraction \< 45%
- Right heart failure (based on the echocardiographic assessment of Right Ventricle Dimension, Tricuspid Annular Plane Systolic Excursion, tricuspid annular velocity, and clinical syndrome)
- Acutely decompensated Heart Failure with preserved Ejection Fraction \<4 weeks
- N-terminal-pro hormone Brain Natriuretic Peptide (NT-proBNP)\> 900 pg/ml for ages 60-75, NT-pro-BNP \> 1800 pg/ml for ages \>75 years
- Presence of chronic systematic inflammatory disease
- Presence of autoimmune disease
- Active malignancy
- History of chemotherapy past 3 years
- Any history of thoracic radiotherapy
- Active treatment with monoclonal antibodies
- Under-treated hypertension
- Under-treated metabolic or endocrine disease
- Acute infection (\<4 weeks)
- Any acute inflammation (\<4 weeks)
- Unstable angina - myocardial infarction past 3 moths
- Stage 4 or 5 Chronic Kidney Disease (as defined by CKD-EPI derived estimated Glomerular Filtration Rate or 24hr urine measurement)
- Any acute renal failure \<4 weeks
- Stroke past 3 months
- Any disabling stroke
- Surgery except for minor procedures past 3 months
- Poor mobility/immobilization
- Life expectancy \< 3 years for any reason
- Difficulty in following follow-up protocol for any reason
- For the control group:
- Known coronary artery disease
- Any heart valve disease, excluding minor valve regurgitation
- Any heart failure
- Pulmonary Hypertension
- Peripheral artery disease
- Presence of chronic systematic inflammatory disease
- Presence of autoimmune disease
- Active malignancy
- History of chemotherapy past 3 years
- Any history of thoracic radiotherapy
- Active treatment with monoclonal antibodies
- Under-treated hypertension
- Under-treated metabolic or endocrine disease
- Acute infection (\<4 weeks)
- Any acute inflammation (\<4 weeks)
- Stage 4 or 5 Chronic Kidney Disease, as defined by the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) derived estimated Glomerular Filtration Rate or 24hr urine measurement
- Any acute renal failure \<4 weeks
- Any stroke
- Surgery except for minor procedures past 3 months
- Poor mobility/immobilization
- Life expectancy \< 3 years for any reason
- Difficulty in following follow-up protocol for any reason
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04312139
Start Date
March 1 2020
End Date
September 1 2025
Last Update
October 4 2022
Active Locations (2)
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1
First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital
Athens, Attica, Greece, 11528
2
Naval Hospital of Athens
Athens, Greece