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/Actively Recruiting
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
Researchers are investigating the effects of angiotensin receptor blockers ARBs on people with mild-to-moderate aortic stenosis, a condition where the hearts 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
Angiotensin Receptor Blockers in Aortic Stenosis
M
Marie-Annick Clavel, PhD
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Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Lead Sponsor
Odense University Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Mulham Ali, Peter Hartmund Frederiksen, Jacob Eifer Møller...
https://pubmed.ncbi.nlm.nih.gov/41730521/Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Lead Sponsor
Odense University Hospital
Collaborating Sponsor