Using angiotensin receptor blockers to treat aortic stenosis
Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial
This study is testing if a common heart medication can help people with mild-to-moderate aortic stenosis by slowing its progression and improving heart function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 20 Years to 99 Years |
| Sex | All |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 2 sites (Québec, Quebec and 1 other locations) |
| Trial ID | NCT04913870 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of angiotensin receptor blockers (ARBs) on patients with mild-to-moderate aortic stenosis. It is a randomized control trial designed to determine whether ARBs can slow the progression of aortic stenosis and reduce left ventricular remodeling and dysfunction. The study is based on previous findings that suggest the renin-angiotensin system may contribute to the worsening of aortic stenosis and myocardial fibrosis. Participants will be assigned to receive either ARBs or a placebo.
Who should consider this trial
Good fit: Ideal candidates are individuals with mild to moderate aortic stenosis and normal left ventricular ejection fraction.
Not a fit: Patients with severe aortic stenosis, significant regurgitation, or other serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could slow the progression of aortic stenosis and improve heart function in affected patients.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential efficacy of ARBs in managing aortic stenosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Québec, Quebec and 1 other locations
- Criucpq — Québec, Quebec, Canada (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Marie-Annick Clavel, PhD — Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study coordinator: Marie-Annick Clavel, PhD
- Email: Marie-Annick.Clavel@criucpq.ulaval.ca
- Phone: 418-656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.