Clinical trial NCT04913870: Angiotensin Receptor Blockers in Aortic Stenosis
Official title: Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Aortic Stenosis
Aortic Valve Stenosis
Keywords: Angiotensin II Receptor Blockers
Left ventricular remodeling
Valvular heart disease
Aortic stenosis
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2021-06-04
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.

Detailed description: Studies support the concept that activation of the renin-angiotensin system may be involved in the progression of valve stenosis and myocardial fibrosis in aortic stenosis. Furthermore recent studies have shown that renin-angiotensin system medication may slow down aortic stenosis progression rate and left ventricle remodeling.

Thus the present study is a randomized control trial to test the efficacy of the angiotensin receptor blocker (ARB) to slow down aortic stenosis progression and left ventricular remodeling/dysfunction in patients with mild-to-moderate aortic stenosis.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate aortic stenosis (peak aortic jet velocity ≥2.5 and \<4m/s)
* Normal left ventricular ejection fraction (i.e. ≥50%)
* Systolic blood pressure \>110 mmHg
* Diastolic blood pressure \>70 mmHg

Exclusion Criteria:

* More than mild aortic or mitral regurgitation, or mitral stenosis
* Current use or documented indication for renin-angiotensin system medication or Aliskiren
* Known allergy or intolerance to angiotensin II receptor blockers (ARBs)
* Alzheimer, dementia or known non-compliant patient
* Renal dysfunction (glomerular filtration rate \<30ml/min/1.73m2)
* Chronic hyperkalemia
* Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment
* Newly diagnosed (\<2 months) or poorly controlled diabetes
* Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (\<3 months)
* Pregnant or lactating women
* Patients unable to read, understand or sign research consent

Primary outcomes:
measure: Change in the anatomic progression of aortic stenosis
timeFrame: Baseline, 2 years
Secondary outcomes:
measure: Change in peak aortic jet velocity
timeFrame: Baseline, 2 years
measure: Change in aortic valve area
timeFrame: Baseline, 2 years
measure: Change in left ventricular (LV) dimension
timeFrame: Baseline, 2 years
measure: Change in left ventricular (LV) mass
timeFrame: Baseline, 2 years
measure: Change in left ventricular (LV) fibrosis
timeFrame: Baseline, 2 years
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CRIUCPQ
state: Quebec
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Marie-Annick Clavel, PhD
role: PRINCIPAL_INVESTIGATOR
References: