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NCT Number: NCT04913870

Angiotensin Receptor Blockers in Aortic Stenosis

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

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Key information

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CRIUCPQ, Québec, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin Receptor Blockers

Drug

Angiotensin Receptor Blockers treatment for 2 years.

Placebo

Other

Placebo administration for 2 years.

Primary outcomes

  1. Change in the anatomic progression of aortic stenosis

    Time frame: Baseline, 2 years

    Aortic valve calcification (measured by MDCT)

Secondary outcomes

  1. Change in peak aortic jet velocity

    Time frame: Baseline, 2 years

    peak aortic jet velocity (Echocardiography)

  2. Change in aortic valve area

    Time frame: Baseline, 2 years

    Aortic valve area (Echocardiography)

  3. Change in left ventricular (LV) dimension

    Time frame: Baseline, 2 years

    LV dimension (Echocardiography, MRI)

  4. Change in left ventricular (LV) mass

    Time frame: Baseline, 2 years

    LV mass (Echocardiography, MRI)

  5. Change in left ventricular (LV) fibrosis

    Time frame: Baseline, 2 years

    LV Fibrosis (MRI)

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Annick Clavel, PhD

CONTACT

[email protected]

418-656-8711 ext. 2678

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

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

Acronym: ARBAS

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2021
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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