LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
NCT ID: NCT05786417
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
741 participants
INTERVENTIONAL
2023-05-10
2027-05-30
Brief Summary
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Detailed Description
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Study Aims Aim 1: To compare the effectiveness of anti-anginal medications to improve the symptoms, function, and quality of life among older adults with multiple chronic conditions presenting with stable angina. Aim 2: To compare the tolerability and safety of commonly used anti-anginal medications in older adults with multiple chronic conditions presenting with stable angina. Aim 3 (Exploratory): To compare the long-term effectiveness and safety of specific anti-anginal medicine treatment approaches in older adults with multiple chronic conditions presenting with stable angina. LIVEBETTER consists of 4 study visits during the 12-month follow-up period. Visits are comprised of an interview, six-minute walk, and medical record review. Medication dose and administration will be addressed as part of routine clinical care.
The importance of the knowledge gained includes the following:
1. LIVEBETTER will produce randomized contemporary data on the safety and efficacy of BBs vs CCBs with the goal of filling that gap of evidence in the guidelines and informing clinical practice.
2. LIVEBETTER will generate data on the quality of life, symptomatic, and functional outcomes most pertinent to older adults with multiple chronic conditions and stable angina.
3. LIVEBETTER will provide the first quantitative data on caregiver burden in older adults with stable angina.
Cognition as measured by the Telephone Interview for Cognitive Status (TICS) is an exploratory endpoint included in the parent LIVEBETTER study. In November 2024, additional exploratory neurocognitive study measures were added as part of an ancillary neurocognitive study funded by the National Institute on Aging in September 2024. Additional measures introduced as part of this ancillary study include an extended cognitive battery and instruments to assess depression and functional status. As part of the ancillary neurocognitive study, study follow-up will be extended to 24 months. The exploratory aims of the neurocognitive ancillary study will be to compare the effect of BB vs. CCB on the rate of cognitive decline and incidence of mild cognitive impairment (MCI) and probable dementia among older adults with stable angina and MCC in the LIVEBETTER randomized clinical trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Beta-Blockers (BB) Therapy
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).
Clinician Discretion
Clinician discretion as to which BB or CCB will be used if the participant has a heart rate and blood pressure within normal limits.
Beta blocker
Selection of the specific BB and initial starting dose will be determined by the treating clinician.
Calcium Channel Blockers (CCB) Therapy
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).
Clinician Discretion
Clinician discretion as to which BB or CCB will be used if the participant has a heart rate and blood pressure within normal limits.
Calcium channel blocker
Selection of the specific CCB and initial starting dose will be determined by the treating clinician.
Interventions
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Clinician Discretion
Clinician discretion as to which BB or CCB will be used if the participant has a heart rate and blood pressure within normal limits.
Beta blocker
Selection of the specific BB and initial starting dose will be determined by the treating clinician.
Calcium channel blocker
Selection of the specific CCB and initial starting dose will be determined by the treating clinician.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Michael Nanna, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale School of Medicine
New Haven, Connecticut, United States
Wellstar Research Institute
Marietta, Georgia, United States
Cook County Health
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mt. Sinai Health System
New York, New York, United States
NYC Health and Hospitals, Harlem Hospital
New York, New York, United States
Nirvana Integrative Medicine
New York, New York, United States
Duke University, School of Medicine
Durham, North Carolina, United States
Inova Health Care Services
Fairfax, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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HA-2021C3-24767
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2000034470
Identifier Type: -
Identifier Source: org_study_id
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