Trials / Recruiting
RecruitingNCT02856620
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
The Role of Cardiac Mechanics, Circulating Biomarkers and Frailty in Aortic Stenosis in Predicting Outcomes After Aortic Valve Intervention.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 450 (estimated)
- Sponsor
- Christine Henri · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational only | Observational only |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2016-08-05
- Last updated
- 2024-11-22
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02856620. Inclusion in this directory is not an endorsement.