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Clinical Trials in Denmark / NCT04913870
Recruiting Phase 4

Angiotensin Receptor Blockers in Aortic Stenosis

NCT04913870 · tracked via the Priya Life Science Denmark tracker
Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Phase
Phase 4
Started
2020-02-01
Last updated
2024-12-20

Condition(s) studied

Aortic StenosisAortic Valve Stenosis

Investigational drug(s) / intervention(s)

Angiotensin Receptor BlockersPlacebo

Angiotensin Receptor Blockers: Angiotensin Receptor Blockers treatment for 2 years.

Placebo: Placebo administration for 2 years.

Study summary

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

Eligibility

Sex
ALL
Min age
20 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in the anatomic progression of aortic stenosis — Baseline, 2 years
    Aortic valve calcification (measured by MDCT)

Trial sites (2)

FacilityCityRegionStatus
CRIUCPQ Québec Quebec Recruiting
Odense University Hospital Odense Denmark Recruiting

Other trials for the same condition

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock Recruiting
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI) Recruiting
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial Active, not recruiting
Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis Active, not recruiting
The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04913870 on ClinicalTrials.gov ↗ ← All trials in Denmark