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LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
RECRUITINGPhase 4Sponsored by Yale University
Actively Recruiting
PhasePhase 4
SponsorYale University
Started2023-05-10
Est. completion2027-05-30
Eligibility
Age65 Years+
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →
NCT05786417
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
Age: 65 Years+Healthy volunteers accepted
Inclusion Criteria:
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:
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 (both) a beta-blocker AND a 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 clinical indication for beta-blockers or calcium channel blockers that precludes dose adjustment or crossover:
1. Diagnosis of acute coronary syndrome (ACS) with reduced ejection fraction 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 consentConditions3
AnginaHeart DiseaseStable Ischemic Heart Disease
Interventions2
Locations10 sites
Find trials near these locations
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Actively Recruiting
PhasePhase 4
SponsorYale University
Started2023-05-10
Est. completion2027-05-30
Eligibility
Age65 Years+
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →
NCT05786417