LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER
Yale University
741 participants
May 10, 2023
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria11
- OLDER ADULTS WITH SIHD AND MCC
- Age ≥65 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:
- positive non-invasive functional or anatomic testing suggestive of obstructive coronary artery disease
- coronary angiography with stenosis ≥70% in a coronary artery ≥2 mm in diameter or
- ≥50% stenosis of left main
- 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 Criteria24
- OLDER ADULTS WITH SIHD AND MCC
- Current taking (both) a beta-blocker AND a calcium channel blocker\*
- Contraindication to beta-blockers or calcium channel blockers including:
- significant hypotension
- high grade AV block
- severe symptomatic bradycardia
- 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 clinical indication for beta-blockers or calcium channel blockers that precludes dose adjustment or crossover:
- Diagnosis of acute coronary syndrome (ACS) with reduced ejection fraction within past year
- 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
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Interventions
Clinician discretion as to which BB or CCB will be used if the participant has a heart rate and blood pressure within normal limits.
Selection of the specific BB and initial starting dose will be determined by the treating clinician.
Selection of the specific CCB and initial starting dose will be determined by the treating clinician.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05786417