Actively Recruiting
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
Led by Christine Henri · Updated on 2024-11-22
450
Participants Needed
1
Research Sites
491 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study) Part I: Observational study to characterize phenotypes, structural alterations and biomarkers profiles in a broad spectrum of patients with aortic stenosis and heart failure with preserved ejection fraction (HFpEF). Part II: Prospective cohort study to characterize patients' phenotypes, cardiac structural alterations, circulating biomarkers and frailty in order to optimize risk stratification and patient selection for aortic valve intervention.
CONDITIONS
Official Title
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients part of the TOPCAT cohort from Americas fulfilling inclusion criteria of Part II-Group 3 and/or patients enrolled in Part II study
- Age 18 years or older
- Aortic stenosis classified by aortic valve area measured by Doppler echocardiography: Moderate AS (1.0-1.5 cm2), Severe AS (1 cm2), or Heart failure with preserved left ventricular ejection fraction (LVEF 6%) without significant AS
- Healthy adults 18 years or older for control group able to sign consent form
You will not qualify if you...
- Prior aortic valve replacement by surgery or transcatheter implantation
- Severe mitral valve disease or aortic valve regurgitation
- Left ventricular ejection fraction less than 45%
- Myocardial infarction within the past 3 months
- Angina limiting 6-Minutes Walk Test distance due to severe coronary artery disease
- Stroke or transient ischemic attack within the past 6 months
- Active infection or cancer
- Renal failure with glomerular filtration rate less than 30 mL/min/1.73 m2 or end-stage renal disease
- Severe anemia (hemoglobin less than 90 g/L) or low platelets (less than 50)
- History of bleeding disorders or blood clotting problems
- Life expectancy under 12 months due to non-heart conditions
- Severe chronic obstructive pulmonary disease (GOLD stages 3-4)
- Musculoskeletal disease limiting ability to perform 6-Minutes Walk Test
- For healthy control group: history of cardiovascular disease, treated diabetes, hypertension, BMI over 30 kg/m2, pregnancy or breastfeeding
- All other exclusions from patient groups apply to control group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
Research Team
H
Helene Brown, RN. B.Sc.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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