Recruiting

Observational Study

Sponsor:

Christine Henri

Code:

NCT02856620

Conditions

Heart Failure

Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observational only

Study Details

Brief summary:

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

Heart Failure

Aortic Stenosis

Study ID

NCT02856620

Start date

Jul, 2016

Status verified date

Nov, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Moderate AS with HF

Severe AS with HF

Moderate AS without HF

Severe AS without HF

HFpEF without AS

Normal age-matched controls

Interventions

Observational only

Observational only

Primary outcome measure

  • 6-Minutes Walk Test Distance (6MWTD) [ Time Frame: 12 to 18 months ]

Central Contacts and Locations

Central contacts

Locations

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

More Information

Sponsor

Christine Henri

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

  • cardiac mechanics
  • circulating biomarkers
  • frailty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christine Henri on 2024-11-22.