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

NCT02856620 | Recruiting

• 1 other identifier: MontrealHI
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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

Keywords

cardiac mechanics; circulating biomarkers; frailty

Outcome Measures

Primary Outcomes (1)

• 6-Minutes Walk Test Distance (6MWTD)

  12 to 18 months

Secondary Outcomes (3)

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  12 to 18 months

• The Physical Ability Score (PAS)

  12 to 18 months

• 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

Study Arms (6)

Moderate AS with HF

Other: Observational only

Severe AS with HF

Other: Observational only

Moderate AS without HF

Other: Observational only

Severe AS without HF

Other: Observational only

HFpEF without AS

Other: Observational only

Normal age-matched controls

Other: Observational only

Interventions

Observational only OTHER

Observational only

HFpEF without AS; Moderate AS with HF; Moderate AS without HF; Normal age-matched controls; Severe AS with HF; Severe AS without HF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Part I: The study population will be recruited from the TOPCAT cohort and Part -II. Part II: Patients will be recruited from cardiology, heart failure, TAVI and cardiac surgery clinics, echocardiography laboratory of the MHI and as for the control group from publicity in and out of the MHI.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christine Henri: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

NT-proBNP hs-TnT sST2 hs-CRP GDF-15

MeSH Terms

Conditions

Heart Failure; Aortic Valve Stenosis; Frailty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine Henri, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene Brown, RN. B.Sc.

CONTACT

514-376-3330; helene.brown@icm-mhi.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 5, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)