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Beta Blocker

Beta Blocker vs Calcium Channel Blocker for Stable Angina (LIVEBETTER Trial)

Phase 4

Recruiting

Led By Michael Nanna, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Age ≥ 75 years

Age ≥ 18 years

Must not have

Current taking beta-blocker or calcium channel blocker*

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial evaluates how well anti-anginal drugs work & are tolerated in older adults w/ SIHD & multiple chronic conditions.

Who is the study for?

This trial is for older adults aged 75 and above with stable angina, heart disease, and at least two other chronic conditions. They must be planning to start medical therapy for their heart condition but can't have severe reactions to beta-blockers or calcium channel blockers, nor plans for immediate complete revascularization.

What is being tested?

The study tests the effectiveness of standard anti-anginal medications (beta-blockers and calcium channel blockers) in managing symptoms of Stable Ischemic Heart Disease in seniors with multiple health issues. The choice of medication is left to the clinician's discretion.

What are the potential side effects?

Potential side effects from beta-blockers may include fatigue, cold hands or feet, weight gain, depression or sleep problems. Calcium channel blockers might cause headaches, swelling in the lower legs and feet, dizziness or constipation.

Eligibility Criteria

Inclusion Criteria

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

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I am 75 years old or older.

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I am 18 years old or older.

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I have two or more long-term health conditions.

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I have heart disease with significant artery blockage and plan to start treatment.

Exclusion Criteria

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

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I am currently taking a beta-blocker or calcium channel blocker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months 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 Quality of Life assessed using EQ-5D-5L

Secondary study objectives

Change in 6-minute walk test

Change in Angina Control assessed using Seattle Angina Questionnaire (SAQ) Summary Score

Change in Caregiver Burden Inventory

+2 more

Awards & Highlights

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.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Calcium Channel Blockers (CCB) TherapyExperimental Treatment2 Interventions

Participants randomized to this arm will be given a calcium channel blocker. Specific and appropriate drug selection from the class of calcium channel blockers (i.e. type of CCB, dosing, and escalation of dose) will be left to the site clinician in accordance with clinical guidelines. All CCB will be administered orally (i.e. pills).

Group II: Beta-Blockers (BB) TherapyExperimental Treatment2 Interventions

Participants randomized to this arm will be given a beta-blocker. Specific and appropriate drug selection from the class of beta blockers (i.e. type of BB, dosing, and escalation of dose) will be left to the site clinician in accordance with clinical guidelines. All BB will be administered orally (i.e. pills).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Beta blocker

2015

Completed Phase 4

~420

0 / 5Eligibility criteria met