NCT04913870 Angiotensin Receptor Blockers in Aortic Stenosis
| NCT ID | NCT04913870 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2020-02-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 144 participants in total. It began in 2020-02-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.
Eligibility 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
Contact & Investigator
Marie-Annick Clavel, PhD
PRINCIPAL INVESTIGATOR
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Frequently Asked Questions
Who can join the NCT04913870 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 99 Years, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04913870 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04913870 currently recruiting?
Yes, NCT04913870 is actively recruiting participants. Contact the research team at Marie-Annick.Clavel@criucpq.ulaval.ca for enrollment information.
Where is the NCT04913870 trial being conducted?
This trial is being conducted at Québec, Canada, Odense, Denmark.
Who is sponsoring the NCT04913870 clinical trial?
NCT04913870 is sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval. The principal investigator is Marie-Annick Clavel, PhD at Institut universitaire de cardiologie et de pneumologie de Québec, University Laval. The trial plans to enroll 144 participants.