A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions

• Status: Not yet recruiting
• Trial end date: 2027-05-30
• Target enrollment: 0
• Participant gender: All

Summary

To establish the effectiveness and tolerability of standard of care anti-anginal treatment (beta-blocker and calcium channel blocker medications) in older adults with symptomatic Stable Ischemic Heart Disease (SIHD) and multiple chronic conditions (MCC).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Adrenergic beta-Antagonists; Calcium; Calcium Channel Blockers

Criteria

Inclusion Criteria:

OLDER ADULTS WITH SIHD AND MCC

• Age ≥ 75 years

• ≥ 2 Multiple Chronic Conditions as defined by Centers for Medicare and Medicaid Services (CMS)

• Diagnosis of Symptomatic Stable Ischemic Heart Disease with plans to initiate medical therapy identified by at least one of the following:

1. positive non-invasive functional or anatomic testing suggestive of obstructive coronary artery disease

2. coronary angiography with stenosis ≥70% in a coronary artery ≥2 mm in diameter or

≥50% stenosis of left main

3. Invasive coronary angiography with positive physiologic testing in at least one vessel (FFR ≤ 0.80 or iFR ≤0.89)

CAREGIVERS

• Age ≥ 18 years

• Identified as caregiver of LIVEBETTER participant

Exclusion Criteria:

OLDER ADULTS WITH SIHD AND MCC

• Current taking beta-blocker or calcium channel blocker*

• Contraindication to beta-blockers or calcium channel blockers including:

1. significant hypotension

2. high grade AV block

3. severe symptomatic bradycardia

4. severe obstructive lung disease

• Documented intolerance to beta-blockers or calcium channel blockers

• Probable or definite high-risk coronary artery disease including unrevascularized left main disease and/or unrevascularized multi-vessel disease including the proximal left anterior descending (LAD) artery with plans for immediate complete revascularization

• Plans for complete revascularization within 2 weeks

• Clear indication for beta-blockers or calcium channel blockers including:

1. Diagnosis of acute coronary syndrome (ACS) within past year

2. Heart failure with reduced ejection fraction (HFrEF) within past year

• Actively participating in another clinical trial involving an investigational medication or device

• Primary language other than English or Spanish

• Inability to complete follow-up (e.g. life expectancy <12 months, impaired decision-making determined by validated instrument)

• Previously enrolled in LIVEBETTER

• Refused informed consent

CAREGIVERS

• Professional caregiver (i.e. not a relative or close friend of the participant)

• Primary language other than English or Spanish

• Inability to complete follow-up

• Previously enrolled in LIVEBETTER

• Refused informed consent