The effect of a combination of beta-blockers, angiotensin receptor blockers, and calcium channel blockers in aortic stenosis

Phase 3

Recruiting

• Conditions: Aortic stenosis; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621001732875
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-20
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

•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.

Exclusion Criteria

•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%
•Pregnancy
•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome of any of aortic valve replacement, hospitalisation with heart failure or aortic stenosis, or cardiovascular death. The outcome will be assessed via the electronic health record and/or by data-linkage with Ministry of Health records.[ The outcome will be assessed annually, for 10 years, with the 5 year assessment as the primary endpoint.]