The Effect of a Combination of Beta-blockers, Angiotensin Receptor Blockers, and Calcium Channel Blockers on Clinical Outcomes in Mild or Moderate Aortic Stenosis (the Pressure Reduction in Mild or Moderate Aortic Stenosis trial)

niversity of Otago0 sites1,250 target enrollmentDecember 20, 2021

Overview

No summary available.

Registry

who.int

Start Date

December 20, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Provide signed and dated informed consent form (analogue or digital).
•Willing to comply with all study procedures and be available for the duration of the study.
•Age between 18 and 90 years, inclusive.
•Systolic BP \<200 and \>100 mmHg.
•Participant has mild to moderate AS as defined by echocardiogram with;
•oaortic valve thickening/calcification and
•omaximum aortic valve transvalvular velocity 2\.5 – 4\.0 m/s and
•omean aortic valve transvalvular gradient (AVG) \<40mmHg and
•oQualitative restriction to valve opening
•Bicuspid or tricuspid aortic valve is eligible for inclusion.

•Major medical comorbidities that, in the opinion of the investigator, would make initiation or adjustment of medications unsafe, or life expectancy is estimated to be less than 5 years.
•Significantly impaired renal function (CKD4 or more significant, i.e. eGFR \< 30ml/min/1\.73m2\).
•Left ventricular ejection fraction \< 50%
•Already prescribed maximal tolerated doses of any one of the investigational antihypertensive regimes (i.e. maximal tolerated dose of (beta\-blocker and angiotensin receptor blocker) or (calcium channel blocker))
•Contraindication to any one of the investigational antihypertensive regimes (i.e. to both beta\-blocker and angiotensin receptor blocker, or to calcium channel blocker)
•Cognitive impairment, dementia, or other limitation that would make the study participant unable to follow dose escalation/study protocols.