Recruiting

Angiotensin Receptor Blockers

Sponsor:

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Code:

NCT04913870

Conditions

Aortic Stenosis

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Angiotensin Receptor Blockers

Placebo

Study Details

Brief summary:

This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.

Conditions

Aortic Stenosis

Aortic Valve Stenosis

Study ID

NCT04913870

Start date

Feb 1, 2020

Status verified date

Mar, 2024

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Mild to moderate aortic stenosis (peak aortic jet velocity ≥2.5 and <4m/s)
  • Normal left ventricular ejection fraction (i.e. ≥50%)
  • Systolic blood pressure >110 mmHg
  • Diastolic blood pressure >70 mmHg

Exclusion Criteria:

  • More than mild aortic or mitral regurgitation, or mitral stenosis
  • 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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Angiotensin Receptor Blockers

Angiotensin Receptor Blockers will be given orally once a day for 2 years.

placebo comparator: Placebo

Participants will receive a matched placebo orally once a day for 2 years.

Interventions

Angiotensin Receptor Blockers

Angiotensin Receptor Blockers treatment for 2 years.

Placebo

Placebo administration for 2 years.

Primary outcome measure

  • Change in the anatomic progression of aortic stenosis [ Time Frame: Baseline, 2 years ]

Central Contacts and Locations

Central contacts

Marie-Annick Clavel, PhD

418-656-8711Marie-Annick.Clavel@criucpq.ulaval.ca

Locations

CRIUCPQ

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Marie-Annick Clavel, PhD

418-656-8711Marie-Annick.Clavel@criucpq.ulaval.ca

418-656-8711

More Information

Sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Last update posted

Dec 20, 2024

Last verified

Mar, 2024

Keywords

  • Angiotensin II Receptor Blockers
  • Left ventricular remodeling
  • Valvular heart disease
  • Aortic stenosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval on 2024-12-20.