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Studies heart and blood markers in people with aortic valve narrowing

Observes heart structure, blood markers and frailty in adults with aortic stenosis.

Plain-language title generated from the registry record
Registry title: The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis

Key facts

Where
Montreal, CanadaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate or severe aortic stenosis, or heart failure with preserved ejection fraction without significant aortic stenosis. It also takes healthy adults as a control group.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Group 1: moderate aortic stenosis (valve area 1.0-1.5cm2). Group 2: severe aortic stenosis (valve area 1cm2). Group 3: heart failure with preserved left ventricular ejection fraction (LVEF ≥45%) without significant aortic stenosis. Control group: healthy people.
Earlier treatment
People who already had aortic valve replacement, by surgery or by valve implantation through a vessel, cannot join.

Main reasons for not taking part

  • Prior aortic valve replacement
  • Severe mitral valve disease or aortic regurgitation
  • LVEF below 45%
  • Heart attack within the previous 3 months
  • Known active infection or cancer

Read by machine on 12 November 2026.

Where in Canada

  • Montreal Heart InstituteMontreal, CanadaContact: Christine Henri, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Christine Henri
Trial code
NCT02856620
Record updated
22 November 2024
Original description
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).Read full original descriptionShow less

The Role of Cardiac Mechanics, Circulating Biomarkers and Frailty in Aortic Stenosis in Predicting Outcomes After Aortic Valve Intervention.

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.

Inclusion: Part I - Patients part of the TOPCAT cohort from Americas fulfilling inclusion criteria of Part II-Group 3 (see below) and/or patients enrolled in the Part II study; Part II - Segment A and B Age ≥ 18 years old AS classified according to aortic valve area measured by Doppler echocardiography Group 1: Moderate AS (1.0-1.5cm2) Group 2: Severe AS (1cm2) Group 3: HF with preserved left ventricular ejection fraction (LVEF ≥45%) without significant AS; Part II - Segment C (Control Group) Age ≥ 18 years old Healthy subject taking into account exclusions parameters at the time of screening Able to sign the consent form.

Exclusion: Part II - Segment C (Control Group) History of cardiovascular disease Risk factors associated with cardiovascular (treated diabetes, hypertension, body mass index >30kg/m2) Pregnancy or breastfeeding All other cause from Segment A and B; Part I and II - Segment A and B Prior AVR either by surgery or trans-aortic valve implantation; Severe mitral valve disease or aortic regurgitation; LVEF < 45% Myocardial infarction within the previous 3 months; Angina limiting the 6MWTD and thought to be the result of severe coronary artery disease; Cerebrovascular transient ischemic attack or stroke within the previous 6 months; Known active infection or cancer; renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) or end-stage renal disease; Significant anemia (haemoglobin <90 g/L) or thrombocytopenia (platelet count <50), history of bleeding diathesis or coagulopathy; Life expectancy <12 months due to non-cardiac co-morbid conditions; Chronic obstructive pulmonary disease with Global initiative for chronic obstructive lung disease (GOLD) stages 3-4; musculoskeletal disease limiting the ability to perform the 6MWTD.

ClinicalTrials.gov NCT02856620