Actively Recruiting

Phase 4
Age: 20Years - 99Years
All Genders
ID04913870

Impact of Angiotensin Receptor Blockers on Mild-to-Moderate Aortic Stenosis A Randomized Controlled Trial Evaluating Progression and Heart Function

Led by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Updated on 2024-12-20

144

Participants Needed

2

Research Sites

365 weeks

Total Duration

On this page

Sponsors

I

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

Lead Sponsor

O

Odense University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of angiotensin receptor blockers (ARBs) on patients with mild-to-moderate aortic stenosis, a condition where the aortic valve narrows and affects heart function. This phase 4 randomized controlled trial aims to determine if ARBs can slow the progression of valve narrowing and reduce remodeling or dysfunction of the left ventricle. The study builds on evidence suggesting that the renin-angiotensin system plays a role in worsening valve stenosis and heart muscle fibrosis. Participants will be randomly assigned to receive either angiotensin receptor blockers or a placebo for a period of two years. The treatments will be administered continuously during this time to evaluate their impact on the progression of aortic stenosis and heart structure changes. Both groups will be closely monitored throughout the study period. During the trial, researchers will assess changes in the anatomical progression of aortic stenosis from the start to the end of the two-year treatment. Participants will undergo regular evaluations to monitor heart function and valve condition. Safety and adherence will also be tracked to ensure participant well-being and accurate measurement of treatment effects over the study duration.

CONDITIONS

Official Title

Angiotensin Receptor Blockers in Aortic Stenosis

Who Can Participate

Age: 20Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mild to moderate aortic stenosis defined by peak aortic jet velocity between 2.5 and less than 4 m/s
  • Normal left ventricular ejection fraction of 50% or higher
  • Systolic blood pressure greater than 110 mmHg
  • Diastolic blood pressure greater than 70 mmHg
Not Eligible

You will not qualify if you...

  • More than mild aortic or mitral valve regurgitation or presence of mitral stenosis
  • Current use or medical indication for renin-angiotensin system medications or Aliskiren
  • Known allergy or intolerance to angiotensin II receptor blockers (ARBs)
  • Diagnosis of Alzheimer’s disease, dementia, or known non-compliance with treatments
  • Renal dysfunction with glomerular filtration rate below 30 ml/min/1.73m2
  • Chronic high potassium levels (hyperkalemia)
  • Diagnosed liver failure, cirrhosis, hepatitis, or history of liver impairment
  • Newly diagnosed diabetes within the past 2 months or poorly controlled diabetes
  • Existing obstructive coronary artery disease with severe angina or recent heart attack within 3 months
  • Pregnant or breastfeeding women
  • Inability to read, understand, or sign the research consent form

AI-Screening

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Trial Site Locations

Total: 2 locations

1

CRIUCPQ

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

2

Odense University Hospital

Odense, Denmark

Actively Recruiting

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Research Team

M

Marie-Annick Clavel, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Invasive Hemodynamic Exercise Response in Hemodynamically Significant Aortic Stenosis With Preserved Left Ventricular Ejection Fraction.

Mulham Ali, Peter Hartmund Frederiksen, Jacob Eifer Møller...

https://pubmed.ncbi.nlm.nih.gov/41730521