Angiotensin Receptor Blockers in Aortic Stenosis

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

Detailed Description
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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.

Official Title
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Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Drug: Angiotensin Receptor Blockers
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angiotensin Receptor Blockers<br>Angiotensin Receptor Blockers will be given orally once a day for 2 years. | Drug: Angiotensin Receptor Blockers<br>* Angiotensin Receptor Blockers treatment for 2 years.<br>|
| Placebo Comparator: Placebo<br>Participants will receive a matched placebo orally once a day for 2 years. | Other: Placebo<br>* Placebo administration for 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the anatomic progression of aortic stenosis | Aortic valve calcification (measured by MDCT) | Baseline, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak aortic jet velocity | peak aortic jet velocity (Echocardiography) | Baseline, 2 years | 
| Change in aortic valve area | Aortic valve area (Echocardiography) | Baseline, 2 years | 
| Change in left ventricular (LV) dimension | LV dimension (Echocardiography, MRI) | Baseline, 2 years | 
| Change in left ventricular (LV) mass | LV mass (Echocardiography, MRI) | Baseline, 2 years | 
| Change in left ventricular (LV) fibrosis | LV Fibrosis (MRI) | Baseline, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiotensin II Receptor Blockers, Left ventricular remodeling, Valvular heart disease, Aortic stenosis