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Recruiting NCT04913870

Angiotensin Receptor Blockers in Aortic Stenosis

Phase IV Interventional Aortic Stenosis Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Angiotensin Receptor Blockers, Placebo.
Who it may be relevant to
Registry conditions: Aortic Stenosis, Aortic Valve Stenosis. Basic parameters: 20 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Angiotensin Receptor Blockers
    Angiotensin Receptor Blockers treatment for 2 years.
  • Other Placebo
    Placebo administration for 2 years.

Primary outcome measures

  • Change in the anatomic progression of aortic stenosis [Time frame: Baseline, 2 years]
Secondary outcome measures (5)
  • Change in peak aortic jet velocity [Time frame: Baseline, 2 years]
  • Change in aortic valve area [Time frame: Baseline, 2 years]
  • Change in left ventricular (LV) dimension [Time frame: Baseline, 2 years]
  • Change in left ventricular (LV) mass [Time frame: Baseline, 2 years]
  • Change in left ventricular (LV) fibrosis [Time frame: Baseline, 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • CRIUCPQ — Québec
Denmark · 1 center
  • Odense University Hospital — Odense

Publications

  • Ali M, Frederiksen PH, Moller JE, Mogensen NSB, Chemnitz A, Haujir A, Poulsen MK, Ovrehus KA, Pibarot P, Pellikka PA, Clavel MA, Dahl JS. Invasive Hemodynamic Exercise Response in Hemodynamically Significant Aortic Stenosis With Preserved Left Ventricular Ejection Fraction. Circ Heart Fail. 2026 Apr;19(4):e012809. doi: 10.1161/CIRCHEARTFAILURE.125.012809. Epub 2026 Feb 23. PMID 41730521

Identifiers

NCT: NCT04913870 · 21617

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗