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Beta-blocker

Discontinuing Beta-Blockers for Ischemic Heart Disease (ABBREVIATE Trial)

Phase 4

Recruiting

Led By Sean van Diepen, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Documented Coronary Artery Disease (CAD) defined as: Myocardial Infarction at least 6 months prior; or Stable ischemic heart disease defined using one of the following tests suggestive of significant coronary artery disease: Positive exercise stress test, Positive Nuclear perfusion scan, Positive exercise or pharmacologic echocardiographic stress test, Positive magnetic resonance imaging coronary perfusion scan, Coronary computed tomographic angiography Angiogram with stenosis ≥ 70% (or left main coronary artery ≥ 50%) or significant function disease based or positive fractional flow reserve testing by CT (FFRCT), Invasive coronary angiography with ≥ 70% (or left main coronary artery ≥ 50%) or significant function disease based or positive fractional flow reserve testing (FFR) or instant wave free ratio (IFR), Previous Percutaneous Coronary Intervention (PCI, at least 6 months prior if revascularization is performed for an MI), Previous Coronary Artery Bypass Grafting (CABG, at least 6 months prior if revascularization is performed for an MI), Able and willing to provide informed consent

Age >21 years

Must not have

Participation in another trial related to β-blockers or other anti-anginal drugs

Left Ventricular Ejection Fraction < 40% or current hospitalization for heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years post randomization

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether it is better to keep or stop taking beta blockers for heart disease. It will also look at how this affects quality of life measures.

Who is the study for?

This trial is for adults over 21 with stable heart disease, documented by tests or past treatments like stents or bypass surgery. They must have had no recent heart attacks and not be hospitalized for heart failure. People can't join if they need beta-blockers for other conditions, have severe heart function issues, uncontrolled blood pressure or chest pain, are non-compliant with meds, have a short life expectancy, or are in another related drug trial.

What is being tested?

The study examines whether stopping beta-blockers is beneficial for patients with stable ischemic heart disease compared to continuing them. It will assess the impact on long-term cardiovascular health and quality of life measures through medical assessments.

What are the potential side effects?

While this study isn't testing new drugs but rather the cessation of an existing one (beta-blockers), potential side effects from discontinuing may include increased risk of chest pain, high blood pressure spikes, and possible worsening of underlying cardiac conditions.

Eligibility Criteria

Inclusion Criteria

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

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I have had heart disease or a heart attack at least 6 months ago and can agree to participate.

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I am older than 21 years.

Exclusion Criteria

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

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I am not currently in a trial for β-blockers or other heart-related drugs.

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My heart's pumping ability is weak or I'm hospitalized for heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years post randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite of time to first all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or heart failure over an estimated four years

Secondary study objectives

angina related quality of life

drug withdrawal

health care costs in each arm

+4 more

Awards & Highlights

Drug Has Already Been Approved

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

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: De-Adoption of Beta-BlockersExperimental Treatment2 Interventions

For patients on β-blocker therapy, medication will be tapered over 3-7 days to minimize the potential for withdrawal-related symptoms. A standardized angina treatment algorithm, which is independent of β-blocker use, will minimize any worsening of angina symptoms during drug withdrawal by utilizing other guideline recommended anti-anginal agents, such as calcium-channel blockers, long acting nitrates, or ivabradine. An anticipated 5% of patients allocated to this arm will not be able to tolerate discontinuation, however, patients will continue participation as per intention-to-treat principle. Background lifestyle measures and medical therapies will be recommended according to current Canadian guideline recommendations and individual patient profiles. Structured algorithms to achieve blood pressure goals that exclude the use of a β-blocker based on the Canadian Hypertension Education Program Guidelines will be provided.

Group II: Continuation of Beta-BlockersExperimental Treatment2 Interventions

For patients already on β-blocker therapy, the treatment will be continued and titrated at the discretion of the patient's most responsible physician(s).

0 / 4Eligibility criteria met