Angiotensin Receptor Blockers in Aortic Stenosis (ARBAS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Aortic Valve Stenosis
• Intervention / Treatment: Drug: Angiotensin Receptor Blockers; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Marie-Annick Clavel, PhD; Phone Number: 2678 418-656-8711; Email: Marie-Annick.Clavel@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Recruiting
      • CRIUCPQ
      • Contact: Marie-Annick Clavel, PhD; Phone Number: 2678 418-656-8711; Email: Marie-Annick.Clavel@criucpq.ulaval.ca
      • Contact: Phone Number: 3868 418-656-8711
      • Contact: Marie-Annick Clavel
• Denmark
  • Odense, Denmark
    • Recruiting
    • Odense University Hospital
    • Contact: Ali Mulham, MD; Phone Number: +4560677621; Email: Mulham.Ali2@rsyd.dk
    • Contact: Jordi Sanchez Dahl, MD, PhD
    • Contact: Ali Mulham, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Collaborators: Odense University Hospital
• Investigators: Principal Investigator: Marie-Annick Clavel, PhD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Aortic stenosis; Valvular heart disease; Left ventricular remodeling; Angiotensin II Receptor Blockers
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic; Molecular Mechanisms of Pharmacological Action; Angiotensin Receptor Antagonists
• Other Study ID Numbers: 21617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No