Aortic Stenosis, Aortic Valve Stenosis
Conditions
Keywords
Angiotensin II Receptor Blockers, Left ventricular remodeling, Valvular heart disease, Aortic stenosis
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.
Interventions
Angiotensin Receptor Blockers treatment for 2 years.
OTHERPlacebo
Placebo administration for 2 years.
Sponsors
Odense University Hospital
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the anatomic progression of aortic stenosis | Baseline, 2 years | Aortic valve calcification (measured by MDCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular (LV) fibrosis | Baseline, 2 years | LV Fibrosis (MRI) |
| Change in peak aortic jet velocity | Baseline, 2 years | peak aortic jet velocity (Echocardiography) |
| Change in aortic valve area | Baseline, 2 years | Aortic valve area (Echocardiography) |
| Change in left ventricular (LV) dimension | Baseline, 2 years | LV dimension (Echocardiography, MRI) |
| Change in left ventricular (LV) mass | Baseline, 2 years | LV mass (Echocardiography, MRI) |
Countries
Canada, Denmark
Contacts
Primary ContactMarie-Annick Clavel, PhD
Outcome results
None listed