Angiotensin Receptor Blockers in Aortic Stenosis (ARBAS)

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Status and phase: Enrolling; Phase 4

Conditions: Aortic Valve Stenosis; Aortic Stenosis

Treatments: Other: Placebo; Drug: Angiotensin Receptor Blockers

Study type: Interventional

Funder types: Other

Identifiers

NCT04913870

21617

Details and patient eligibility

About

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

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

Angiotensin Receptor Blockers

Experimental group

Description:

Angiotensin Receptor Blockers will be given orally once a day for 2 years.

Treatment:

Drug: Angiotensin Receptor Blockers

Placebo

Placebo Comparator group

Description:

Participants will receive a matched placebo orally once a day for 2 years.

Treatment:

Other: Placebo