Serum and Cellular Biomarkers for Aortic Valve Stenosis

Launched by NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS · Mar 14, 2020

Keywords

ClinConnect Summary

The AthenaValve clinical trial is studying a new blood test that could help doctors better understand how severe aortic valve stenosis (narrowing of the heart's aortic valve) is and how quickly it might get worse. The goal is to develop a diagnostic kit that can identify patients at high risk for this condition early on, which is important because early treatment can make a significant difference in outcomes. Researchers will analyze blood samples from two different groups of patients, as well as from an animal model, to find specific substances in the blood that can serve as indicators of the disease.

To participate in this trial, you may be eligible if you have been diagnosed with severe or moderate aortic valve stenosis based on specific measurements from heart ultrasound tests. This includes people who have had previous tests showing that their condition is worsening. Participants can expect to provide blood samples and may help advance new methods for diagnosing and treating this serious heart condition. It's important to note that there are specific health conditions that would exclude someone from participating, so it's best to discuss any concerns with your healthcare provider.

Gender

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Eligibility criteria

• Inclusion Criteria:
• * 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 Criteria:
• • 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