Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling

Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03411317

Acronym

AS-PROGRESSION

Enrollment

350

Registered

2018-01-26

Start date

2017-12-11

Completion date

2025-12-31

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Aortic stenosis, progression, Left ventricular remodeling

Brief summary

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI). AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified. The aim of the study is to evaluate prospectively the progression and impact of AS in 500 patients using clinical, biological, echocardiographic and MRI parameters performed annually.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Aortic stenosis (peak aortic valve velocity (Vmax) ≥2.5m/s )

Exclusion criteria

* rheumatismal or congenital aortic stenosis * aortic insufficiency (grade \>= 2/4) * Associated valvulopathy (grade \>= 2/4) * Angina, syncope, dyspnea NYHA 3-4 * Heart failure antecedent * Myocardial infarction antecedent * Severe renal failure * indication of Aortic Valve Replacement (Surgery or TAVI) * Cardiac surgery (Aorta abdominal) antecedent * Complex congenital cardiopathy

Design outcomes

Primary

Measure	Time frame	Description
Composite primary endpoint: haemodynamic and anatomical progression of Aortic Stenosis	Year 1	CT scan and MRI

Secondary

Measure	Time frame	Description
Progression of left ventricular remodeling	Year 1	MRI and echocardiography
Prognostic value of ventricular mass, type of ventricular remodeling and fibrosis in Aortic Stenosis	Year 1	Occurrence of clinical events, MRI, CT scan and echocardiography
Determinants of left ventricular remodeling	Year 1	MRI and echocardiography

Countries

France

Outcome results