8500 Participants Needed

Discontinuing Beta-Blockers for Ischemic Heart Disease

(ABBREVIATE Trial)

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Overseen BySean van Diepen, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients with heart disease are often prescribed many medications and these patients may experience drug interactions or negative drug related side effects. With newer medications and treatments available, it is not well known whether older drugs, such as beta-blockers, are still an effective and safe option for treating heart disease. Some evidence suggests beta-blockers should be continued, whereas other evidence suggests beta-blockers might cause unnecessary harm. The study hopes to determine whether continuation or discontinuation of beta-blockers will affect long term cardiovascular outcomes. The study investigators will also examine how beta-blockers continuation or discontinuation affects several quality of life measures.

Will I have to stop taking my current medications?

The trial focuses on whether to continue or stop taking beta-blockers for heart disease. If you are currently on beta-blockers, the study may require you to stop taking them, but it doesn't specify about other medications.

Is it safe to discontinue beta-blockers for ischemic heart disease?

Modern beta-blockers like metoprolol, bisoprolol, atenolol, and carvedilol are generally safe with a low risk of serious side effects when used properly. However, they can cause issues like slow heart rate, breathing problems, or worsening heart failure if not managed correctly.12345

How do beta-blockers differ from other drugs for ischemic heart disease?

Beta-blockers, like atenolol and bisoprolol, are unique because they reduce heart rate and blood pressure, which helps the heart work less hard. They are particularly effective after a heart attack and in managing heart failure, offering a protective effect that other treatments may not provide.14567

What data supports the effectiveness of beta-blockers for ischemic heart disease?

Research shows that beta-blockers like atenolol and bopindolol can reduce the incidence of angina (chest pain due to heart disease) and lower heart rate, which may help manage symptoms of ischemic heart disease. Additionally, beta-blockers such as carvedilol, metoprolol, and bisoprolol have been shown to improve survival and symptoms in heart failure, suggesting potential benefits for heart-related conditions.4891011

Who Is on the Research Team?

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Sean van Diepen, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had heart disease or a heart attack at least 6 months ago and can agree to participate.
I am older than 21 years.

Exclusion Criteria

My doctor has prescribed β-blockers for my heart condition.
I have not had a heart attack in the last 6 months.
I am not currently in a trial for β-blockers or other heart-related drugs.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either continue or discontinue β-blocker therapy, with discontinuation involving a tapering process over 3-7 days

3-7 days

Follow-up

Participants are monitored remotely for adherence, events, outcomes assessments, and quality of life over approximately four years

4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Beta-blockers
Trial Overview 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.
How Is the Trial Designed?
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).

Beta-blockers is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Beta-blockers for:
  • Hypertension
  • Angina pectoris
  • Heart failure
  • Myocardial infarction
  • Arrhythmias
🇺🇸
Approved in United States as Beta-blockers for:
  • Hypertension
  • Angina pectoris
  • Heart failure
  • Myocardial infarction
  • Arrhythmias
🇨🇦
Approved in Canada as Beta-blockers for:
  • Hypertension
  • Angina pectoris
  • Heart failure
  • Myocardial infarction
  • Arrhythmias

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Published Research Related to This Trial

Bopindolol, a new non-selective beta-blocker, showed a lesser reduction in heart rate compared to atenolol, with a 13% decrease versus a 24% decrease, indicating it may have a milder beta-blocking effect.
Unlike atenolol, which did not affect cardiac contractility, bopindolol increased contractility, suggesting it may have potential benefits in treating coronary artery disease, although further evidence is needed.
Haemodynamic effects of bopindolol and atenolol in coronary artery disease. A noninvasive study.Rapola, JM., Pellinen, TJ., Toivonen, L., et al.[2019]
In a study of 29 heart failure patients, replacing carvedilol with propranolol did not worsen heart function, as measured by ejection fraction, after 6 months, indicating that propranolol can be a safe alternative.
The study found that propranolol led to a significant increase in ejection fraction, suggesting it may be effective in improving heart function in patients previously stabilized on carvedilol.
Replacement of carvedilol for propranolol in patients with heart failure.Marques, F., Castro, RB., Nobre, F., et al.[2019]
β-blockers are no longer recommended as the first-line treatment for primary hypertension because they are less effective than other antihypertensive medications and do not perform better than a placebo, despite their ability to lower blood pressure.
There are significant differences in the pharmacological and physiological effects among different β-blockers, with carvedilol showing less metabolic dysregulation compared to others, which may influence their clinical use in treating cardiovascular diseases.
β-blockers: a review of their pharmacological and physiological diversity in hypertension.Ripley, TL., Saseen, JJ.[2018]

Citations

Haemodynamic effects of bopindolol and atenolol in coronary artery disease. A noninvasive study. [2019]
Replacement of carvedilol for propranolol in patients with heart failure. [2019]
β-blockers: a review of their pharmacological and physiological diversity in hypertension. [2018]
Bopindolol and atenolol in patients with stable angina pectoris. Double-blind randomized comparative trial. [2018]
Are all beta-blockers the same for chronic heart failure? [2019]
[Differential therapy with beta blockers. What is their value, what are the risks?]. [2017]
Effect of new beta-adrenergic blocking agent, Atenolol (Tenormin), on pain frequency, trinitrin consumption, and exercise ability. [2019]
8.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Efficacy and safety of different beta-blockers in patients with isolated systolic hypertension associated with diabetes mellitus and obstructive pulmonary diseases]. [2013]
Haemodynamic effects of atenolol and bopindolol at rest and during isometric exercise. A non-invasive study in healthy volunteers. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Effect of Bisoprolol and Atenolol on Left Ventricular Mass in Patients with Essential Hypertension. [2019]
[Beta-blocker intoxication]. [2016]
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