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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years post randomization
Awards & highlights
ABBREVIATE Trial 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.Check my eligibility
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.See study design
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.
ABBREVIATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had heart disease or a heart attack at least 6 months ago and can agree to participate.
Select...
I am older than 21 years.
ABBREVIATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
angina related quality of life
drug withdrawal
health care costs in each arm
+4 moreABBREVIATE 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).
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
376,634 Total Patients Enrolled
4 Trials studying Ischemic Heart Disease
797 Patients Enrolled for Ischemic Heart Disease
Sean van Diepen, MDPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
710 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor has prescribed β-blockers for my heart condition.I have not had a heart attack in the last 6 months.I have had heart disease or a heart attack at least 6 months ago and can agree to participate.I am not currently in a trial for β-blockers or other heart-related drugs.I am older than 21 years.My heart's pumping ability is weak or I'm hospitalized for heart failure.You have high blood pressure that is not under control, or you have symptoms of angina that are not under control.You do not follow your doctor's instructions for taking medicine.You are expected to live less than 1 year.
Research Study Groups:
This trial has the following groups:- Group 1: De-Adoption of Beta-Blockers
- Group 2: Continuation of Beta-Blockers
Awards:
This trial has 3 awards, including:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this medical intervention obtained regulatory endorsement?
"This treatment's safety has been confirmed through extensive clinical trials, so it receives an impressive score of 3."
Answered by AI
Is this experiment available to participants currently?
"According to clinicaltrials.gov, the medical study in question is not currently enlisting patients. Initially posted on December 1st 2022 and last updated November 7th of the same year, this trial does not require participants at this time; however, there are more than 1000 other studies actively searching for volunteers right now."
Answered by AI
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