Angiotensin Receptor Blockers in Aortic Stenosis

Aortic Stenosis Clinical Trial

— ARBAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913870
• Other study ID #: 21617
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: February 2025

Study information

• Verified date: November 2022
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: Marie-Annick Clavel, PhD
• Phone: 418-656-8711
• Email: Marie-Annick.Clavel[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Drug:
• Angiotensin Receptor Blockers
Angiotensin Receptor Blockers treatment for 2 years.

Other:
• Placebo
Placebo administration for 2 years.

Locations

Country	Name	City	State
Canada	CRIUCPQ	Québec	Quebec
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval	Odense University Hospital

Countries where clinical trial is conducted

Canada,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the anatomic progression of aortic stenosis	Aortic valve calcification (measured by MDCT)	Baseline, 2 years
Secondary	Change in peak aortic jet velocity	peak aortic jet velocity (Echocardiography)	Baseline, 2 years
Secondary	Change in aortic valve area	Aortic valve area (Echocardiography)	Baseline, 2 years
Secondary	Change in left ventricular (LV) dimension	LV dimension (Echocardiography, MRI)	Baseline, 2 years
Secondary	Change in left ventricular (LV) mass	LV mass (Echocardiography, MRI)	Baseline, 2 years
Secondary	Change in left ventricular (LV) fibrosis	LV Fibrosis (MRI)	Baseline, 2 years