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

Heart Failure Clinical Trial

— SCRABLES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02856620
• Other study ID #: MontrealHI
• Status: Recruiting
• Start date: July 2016
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Montreal Heart Institute
• Contact: Helene Brown, RN. B.Sc.
• Phone: 514-376-3330
• Email: helene.brown[@]icm-mhi.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Part I: This part will be an observational exploratory analysis to collate available data from Treatment of preserved cardiac function heart failure with an aldosterone antagonist trial (TOPCAT) cohort regarding the potential role of clinical phenotype, structural alterations and biomarkers profiles that can help determine symptom severity in a AS and HFpEF, and offer insights into which patients with AS may suffer from HFpEF after aortic valve replacement (AVR).

Part II: This part will be a prospective cohort study to create an AS functional capacity score that will include phenotypic classification, structural alterations using novel echocardiographic parameters such as cardiac mechanics, biomarkers profiles and frailty evaluation in order to more accurately predict functional capacity before (Segment A) and after aortic valve intervention (Segment B) and to compare with healthy control group (Segment C).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Frailty
• Heart Failure

Intervention

Other:
• Observational only
Observational only

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Christine Henri

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Minutes Walk Test Distance (6MWTD)		12 to 18 months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)		12 to 18 months
Secondary	The Physical Ability Score (PAS)		12 to 18 months
Secondary	Occurrence of major adverse events defined as stroke, myocardial infarction, pacemaker implantation, prolonged (>14 days) or re-hospitalization, lack of reduction in doses of diuretics, new onset of heart failure and mortality		12 to 18 months