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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
Locations9 sites

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 consent

Conditions3

AnginaHeart DiseaseStable Ischemic Heart Disease

Locations9 sites

Yale School of Medicine
New Haven, Connecticut, 06520
Wellstar Research Institute
Marietta, Georgia, 30060
Cook County Health
Chicago, Illinois, 60612
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Mt. Sinai Health System
New York, New York, 10029

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