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Angiotensin Receptor Blockers

Angiotensin Receptor Blockers for Aortic Stenosis (ARBAS Trial)

Q: Is eligibility for this research restricted to individuals under 70 years of age?

This medical trial requires applicants to be aged between 20 and 99, in order for them to meet the necessary eligibility criteria.

Q: Do I meet the requirements necessary to participate in this experiment?

Qualified applicants for this medical trial must demonstrate constriction, pathology and range between 20-99 years old. Recruitment is projected to include 144 patients in total.

Q: How many participants has this trial recruited?

Affirmative. Clinicaltrials.gov confirms that this experiment, which was first advertised on February 1st 2020, is actively searching for suitable candidates. 144 participants are needed from a single medical establishment.

Q: Has the FDA granted clearance to Angiotensin Receptor Blockers?

We rated the safety of Angiotensin Receptor Blockers a 3, as this is a Phase 4 trial and thus has been approved.

Q: Is this research project currently accepting new participants?

Affirmative! Records on clinicaltrials.gov affirm that this medical trial, originally posted on February 1st 2020, is actively recruiting for 144 patients from a single site. The listing was refreshed most recently on November 12th 2022.

Phase 4

Recruiting

Led By Marie-Annick Clavel, PhD

Research Sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mild to moderate aortic stenosis (peak aortic jet velocity ≥2.5 and <4m/s)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 years

Awards & highlights

ARBAS Trial Summary

This trial will study the effect of ARBs on mild-to-moderate aortic stenosis.

Who is the study for?

This trial is for adults with mild to moderate aortic stenosis, normal heart pump function, and stable blood pressure. It's not for those with certain heart valve issues, on specific heart medications, allergic to ARBs, cognitive impairments like Alzheimer's or dementia, severe kidney problems, chronic high potassium levels, serious liver conditions, recent diabetes diagnosis or uncontrolled diabetes, advanced coronary artery disease or recent heart attack.Check my eligibility

What is being tested?

The study examines the effects of angiotensin receptor blockers (ARBs) compared to a placebo in patients with mild-to-moderate aortic stenosis. Participants will be randomly assigned to receive either the ARB medication or an inactive substance without any active drug (placebo).See study design

What are the potential side effects?

Possible side effects of ARBs may include dizziness due to low blood pressure especially after standing up quickly (orthostatic hypotension), headache, fatigue and occasionally increased potassium levels which can affect your heartbeat.

ARBAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart valve narrowing is mild to moderate.

ARBAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the anatomic progression of aortic stenosis

Secondary outcome measures

Change in aortic valve area

Change in left ventricular (LV) dimension

Change in left ventricular (LV) fibrosis

+2 more

ARBAS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Angiotensin Receptor BlockersExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiotensin Receptor Blockers

2020

Completed Phase 4

~940

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Odense University HospitalOTHER

754 Previous Clinical Trials

1,168,782 Total Patients Enrolled

Institut universitaire de cardiologie et de pneumologie de Québec, University LavalLead Sponsor

18 Previous Clinical Trials

3,339 Total Patients Enrolled

Marie-Annick Clavel, PhDPrincipal InvestigatorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

1 Previous Clinical Trials

1,500 Total Patients Enrolled

Media Library

Angiotensin Receptor Blockers (Angiotensin Receptor Blockers) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04913870 — Phase 4

Aortic Stenosis Research Study Groups: Angiotensin Receptor Blockers, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this research restricted to individuals under 70 years of age?

"This medical trial requires applicants to be aged between 20 and 99, in order for them to meet the necessary eligibility criteria."

Answered by AI

Do I meet the requirements necessary to participate in this experiment?

"Qualified applicants for this medical trial must demonstrate constriction, pathology and range between 20-99 years old. Recruitment is projected to include 144 patients in total."

Answered by AI

How many participants has this trial recruited?

"Affirmative. Clinicaltrials.gov confirms that this experiment, which was first advertised on February 1st 2020, is actively searching for suitable candidates. 144 participants are needed from a single medical establishment."

Answered by AI

Has the FDA granted clearance to Angiotensin Receptor Blockers?

"We rated the safety of Angiotensin Receptor Blockers a 3, as this is a Phase 4 trial and thus has been approved."

Answered by AI

Is this research project currently accepting new participants?

"Affirmative! Records on clinicaltrials.gov affirm that this medical trial, originally posted on February 1st 2020, is actively recruiting for 144 patients from a single site. The listing was refreshed most recently on November 12th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Angiotensin Receptor Blockers in Aortic Stenosis

Marie-Annick Clavel 2020. "Angiotensin Receptor Blockers in Aortic Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04913870.

All > Aortic Stenosis