Angiotensin Receptor Blockers in Aortic Stenosis

Phase 4RecruitingNCT04913870

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval144 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

144

Conditions

Aortic Stenosis Aortic Valve Stenosis

Interventions

Angiotensin Receptor BlockersDRUG

Angiotensin Receptor Blockers treatment for 2 years.

PlaceboOTHER

Placebo administration for 2 years.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (2)

CRIUCPQ

Québec, Quebec, Canada

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Outcomes

Primary Outcomes

Change in the anatomic progression of aortic stenosis

Aortic valve calcification (measured by MDCT)

Time frame: Baseline, 2 years

Secondary Outcomes

Change in peak aortic jet velocity

peak aortic jet velocity (Echocardiography)

Time frame: Baseline, 2 years

Change in aortic valve area

Aortic valve area (Echocardiography)

Time frame: Baseline, 2 years

Change in left ventricular (LV) dimension

LV dimension (Echocardiography, MRI)

Time frame: Baseline, 2 years

Change in left ventricular (LV) mass

LV mass (Echocardiography, MRI)

Time frame: Baseline, 2 years

Change in left ventricular (LV) fibrosis

LV Fibrosis (MRI)

Time frame: Baseline, 2 years

Central Contacts

Marie-Annick Clavel, PhD

CONTACT

418-656-8711 Marie-Annick.Clavel@criucpq.ulaval.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.