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/41730521Actively Recruiting
Phase 4
Age: 20Years - 99Years
All Genders
ID04913870
Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial
Led by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Updated on 2024-12-20
144
Participants Needed
2
Research Sites
N/A
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 investigating the effects of angiotensin receptor blockers (ARBs) on people with mild-to-moderate aortic stenosis, a condition where the heart's aortic valve narrows and affects blood flow. The study explores whether ARBs can slow the progression of this valve narrowing and reduce changes in the heart muscle. This is a randomized controlled trial aiming to test the impact of ARBs on valve stenosis and heart remodeling in affected patients. Participants will be randomly assigned to receive either an angiotensin receptor blocker or a placebo, both taken orally once daily for two years. The study compares the changes in aortic stenosis progression and heart structure between these two groups over this period. The trial uses a quadruple masking design to ensure unbiased results. During the study, participants will undergo evaluations at the start and after two years, measuring changes in the anatomy of aortic stenosis, peak aortic jet velocity, aortic valve area, left ventricular size, mass, and fibrosis. Researchers will monitor these heart function markers to assess the treatment effect. The total participation time spans two years with regular assessments to track safety and heart health changes.
CONDITIONS
Brief Title
Angiotensin Receptor Blockers in Aortic Stenosis
Who Can Participate
Age: 20Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Mild to moderate aortic stenosis with peak aortic jet velocity between 2.5 and less than 4 m/s
- Normal left ventricular ejection fraction (50% or higher)
- Systolic blood pressure greater than 110 mmHg
- Diastolic blood pressure greater than 70 mmHg
You will not qualify if you...
- More than mild aortic or mitral regurgitation, or mitral stenosis
- Current use or documented need for renin-angiotensin system medication or Aliskiren
- Known allergy or intolerance to angiotensin II receptor blockers (ARBs)
- Alzheimer disease, dementia, or known patient non-compliance
- Renal dysfunction with glomerular filtration rate less than 30 ml/min/1.73m2
- Chronic high potassium levels (hyperkalemia)
- Diagnosed liver failure, cirrhosis, hepatitis, or history of liver problems
- Newly diagnosed or poorly controlled diabetes within 2 months
- Pre-existing obstructive coronary artery disease with severe angina or recent heart attack within 3 months
- Pregnant or breastfeeding women
- Patients unable to read, understand, or sign research consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 years
Participants receive either angiotensin receptor blockers or placebo orally once a day to slow down the progression of aortic stenosis and left ventricular remodeling.
Regular visits to monitor health and medication adherence
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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