NCT02856620 The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
| NCT ID | NCT02856620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Christine Henri |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2016-07 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2016-07 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Christine Henri, MD
PRINCIPAL INVESTIGATOR
Montreal Heart Institute
Frequently Asked Questions
Who can join the NCT02856620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02856620 currently recruiting?
Yes, NCT02856620 is actively recruiting participants. Contact the research team at helene.brown@icm-mhi.org for enrollment information.
Where is the NCT02856620 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT02856620 clinical trial?
NCT02856620 is sponsored by Christine Henri. The principal investigator is Christine Henri, MD at Montreal Heart Institute. The trial plans to enroll 450 participants.
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