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The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis

Heart Failure | Aortic Stenosis

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

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 Criteria:

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.

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

Study Location

Montreal Heart Institute
Montreal Heart Institute
Montreal, Quebec
Canada

Contact Study Team

Backup Contact

Helene Brown, RN. B.Sc.

[email protected]
514-376-3330
Primary Contact

Christine Henri, MD

[email protected]
514-376-3330
Study Sponsored By
Montreal Heart Institute
Participants Required
More Information
Study ID: NCT02856620