What side effects are associated with this type of intervention?

Common treatments for aortic stenosis include surgical interventions like valve replacement and medications such as Angiotensin Receptor Blockers (ARBs). ARBs, which block angiotensin II receptors, are generally well-tolerated but can cause side effects such as dizziness, hyperkalemia (high potassium levels), hypotension (low blood pressure), and renal impairment. Other treatments, like beta-blockers and diuretics, may also be used but come with their own side effects, including fatigue, electrolyte imbalances, and increased risk of diabetes.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of aortic stenosis using angiotensin receptor blockers (ARBs) in the provided context. However, ARBs are commonly used in managing cardiovascular conditions due to their ability to block angiotensin II receptors, which helps in reducing blood pressure and improving heart function. The study mentioned aims to investigate the effect of ARBs on mild-to-moderate aortic stenosis, which could potentially expand their use in this specific condition if proven effective.

What other types of research exist?

Promising novel alternatives to Angiotensin Receptor Blockers for Aortic Stenosis patients may include Sacubitril/Valsartan (an ARNI) and potentially SGLT2 inhibitors or GLP1 receptor agonists, given their cardiovascular benefits observed in other conditions. Consultation with a healthcare provider is essential to determine the most appropriate treatment.

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Angiotensin Receptor Blockers

Angiotensin Receptor Blockers for Aortic Stenosis (ARBAS Trial)

Q: What is the mechanism of action of this treatment?

Angiotensin Receptor Blockers (ARBs) treat Aortic Stenosis (AS) by blocking angiotensin II receptors, leading to vasodilation and reduced blood pressure. This decreases the workload on the heart and helps manage the increased pressure gradient across the aortic valve, which is crucial for AS patients as it can slow disease progression and alleviate symptoms.

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

Must not have

More than mild aortic or mitral regurgitation, or mitral stenosis

Known allergy or intolerance to angiotensin II receptor blockers (ARBs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether medications that help relax blood vessels can slow down the worsening of aortic stenosis and heart muscle problems. The study focuses on patients with mild-to-moderate aortic stenosis. These medications work by blocking chemicals that can make these heart conditions worse. They are a new class of drugs with broad therapeutic potential in cardiovascular disease.

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.

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).

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have moderate to severe heart valve issues.

Select...

I am allergic to or cannot tolerate ARBs.

Select...

I have long-term high potassium levels.

Select...

I am currently taking or need medication for my blood pressure.

Select...

My kidney function is low.

Select...

I have a history of liver problems.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the anatomic progression of aortic stenosis

Secondary study objectives

Change in aortic valve area

Change in left ventricular (LV) dimension

Change in left ventricular (LV) fibrosis

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Angiotensin Receptor Blockers (ARBs) treat Aortic Stenosis (AS) by blocking angiotensin II receptors, leading to vasodilation and reduced blood pressure. This decreases the workload on the heart and helps manage the increased pressure gradient across the aortic valve, which is crucial for AS patients as it can slow disease progression and alleviate symptoms.