Angiotensin Receptor Blockers in Aortic Stenosis

Phase 4

Recruiting

• Conditions: Aortic Stenosis; Aortic Valve Stenosis
• Interventions: Other: Placebo; Drug: Angiotensin Receptor Blockers

• Registration Number: NCT04913870
• Lead Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive a matched placebo orally once a day for 2 years.
Angiotensin Receptor Blockers	Angiotensin Receptor Blockers	Angiotensin Receptor Blockers will be given orally once a day for 2 years.

Primary Outcome Measures

Name	Time	Method
Change in the anatomic progression of aortic stenosis	Baseline, 2 years	Aortic valve calcification (measured by MDCT)

Secondary Outcome Measures

Name	Time	Method
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)
Change in left ventricular (LV) fibrosis	Baseline, 2 years	LV Fibrosis (MRI)

Trial Locations

Locations (2)

CRIUCPQ; 🇨🇦 Québec, Quebec, Canada

Odense University Hospital; 🇩🇰 Odense, Denmark