Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
144 participants
INTERVENTIONAL
2020-02-01
2027-02-28
Brief Summary
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Detailed Description
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Thus the present study is a randomized control trial to test the efficacy of the angiotensin receptor blocker (ARB) to slow down aortic stenosis progression and left ventricular remodeling/dysfunction in patients with mild-to-moderate aortic stenosis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Angiotensin Receptor Blockers
Angiotensin Receptor Blockers will be given orally once a day for 2 years.
Angiotensin Receptor Blockers
Angiotensin Receptor Blockers treatment for 2 years.
Placebo
Participants will receive a matched placebo orally once a day for 2 years.
Placebo
Placebo administration for 2 years.
Interventions
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Angiotensin Receptor Blockers
Angiotensin Receptor Blockers treatment for 2 years.
Placebo
Placebo administration for 2 years.
Eligibility Criteria
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Inclusion Criteria
* Normal left ventricular ejection fraction (i.e. ≥50%)
* Systolic blood pressure \>110 mmHg
* Diastolic blood pressure \>70 mmHg
Exclusion Criteria
* Current use or documented indication for renin-angiotensin system medication or Aliskiren
* Known allergy or intolerance to angiotensin II receptor blockers (ARBs)
* Alzheimer, dementia or known non-compliant patient
* Renal dysfunction (glomerular filtration rate \<30ml/min/1.73m2)
* Chronic hyperkalemia
* Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment
* Newly diagnosed (\<2 months) or poorly controlled diabetes
* Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (\<3 months)
* Pregnant or lactating women
* Patients unable to read, understand or sign research consent
20 Years
99 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
OTHER
Responsible Party
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Marie-Annick Clavel
Full Professor
Principal Investigators
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Marie-Annick Clavel, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Locations
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CRIUCPQ
Québec, Quebec, Canada
Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Marie-Annick Clavel, PhD
Role: primary
Role: backup
Marie-Annick Clavel
Role: backup
Ali Mulham, MD
Role: primary
Jordi Sanchez Dahl, MD, PhD
Role: backup
Ali Mulham, MD
Role: backup
Other Identifiers
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21617
Identifier Type: -
Identifier Source: org_study_id