Understanding heart function and biomarkers in aortic stenosis patients
The Role of Cardiac Mechanics, Circulating Biomarkers and Frailty in Aortic Stenosis in Predicting Outcomes After Aortic Valve Intervention.
This study is trying to see how heart function, certain blood markers, and overall health can help predict how well patients with aortic stenosis do after getting their heart valve replaced.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montreal Heart Institute Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT02856620 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of cardiac mechanics, biomarkers, and frailty in predicting outcomes for patients with aortic stenosis after undergoing aortic valve replacement. It consists of two parts: the first part analyzes existing data to identify phenotypes and biomarkers that indicate symptom severity in patients with aortic stenosis and heart failure with preserved ejection fraction. The second part is a prospective cohort study aimed at developing a functional capacity score that incorporates various clinical and structural parameters to enhance risk stratification and patient selection for aortic valve interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with moderate to severe aortic stenosis or heart failure with preserved ejection fraction.
Not a fit: Patients who have previously undergone aortic valve replacement or have significant mitral valve disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection and outcomes for those undergoing aortic valve replacement.
How similar studies have performed: Other studies have shown promise in using biomarkers and cardiac mechanics for patient stratification, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Christine Henri, MD — Montreal Heart Institute
- Study coordinator: Helene Brown, RN. B.Sc.
- Email: helene.brown@icm-mhi.org
- Phone: 514-376-3330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.