LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
LIVEBETTER
A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER
3 other identifiers
interventional
741
1 country
9
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2023
Longer than P75 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedStudy Start
First participant enrolled
May 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
December 3, 2025
February 1, 2025
4.1 years
March 13, 2023
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Quality of Life assessed using EQ-5D-5L
The EQ-5D-5L represents a global quality of life measure that includes multiple components potentially impacted by the anti-anginal treatments being examined. The EQ-5D-5L score includes questions on mobility, self-care, usual activities, anxiety/depression, and pain/discomfort on a 5-point scale: 1=No Problem, 2=Slight Problem, 3=Moderate Problem, 4=Severe Problem, 5=Extreme Problem or Inability. 0, 1, and negative values corresponding to death, full health, and health states worse than death, respectively. Higher scores indicated greater levels of problems across each of the five dimensions.
Baseline and 45 days
Secondary Outcomes (6)
Change in Persistence on medication
up to 6 months
Change in Quality of Life assessed using EQ-5D-5L
Baseline, 6 months, 12 months, 24 months
Change in Quality of Life assessed using PROMIS® Scale v1.2 - Global Health
Baseline, 45 days, 6 months, 12 months, 24 months
Change in Angina Control assessed using Seattle Angina Questionnaire (SAQ) Summary Score
Baseline, 45 days, 6 months, 12 months, 24 months
Change in 6-minute walk test
Baseline and 45 days
- +1 more secondary outcomes
Study Arms (2)
Beta-Blockers (BB) Therapy
EXPERIMENTALParticipants 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).
Calcium Channel Blockers (CCB) Therapy
EXPERIMENTALParticipants 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).
Interventions
Selection of the specific BB and initial starting dose will be determined by the treating clinician.
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 CCB and initial starting dose will be determined by the treating clinician.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (9)
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Wellstar Research Institute
Marietta, Georgia, 30060, United States
Cook County Health
Chicago, Illinois, 60612, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Mt. Sinai Health System
New York, New York, 10029, United States
NYC Health and Hospitals, Harlem Hospital
New York, New York, 10037-1802, United States
Nirvana Integrative Medicine
New York, New York, 10469, United States
Duke University, School of Medicine
Durham, North Carolina, 27710, United States
Inova Health Care Services
Fairfax, Virginia, 22033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Nanna, MD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 27, 2023
Study Start
May 10, 2023
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
December 3, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
Participant data will be available but de-identified and deposited into a Patient-Centered Outcomes Research Institute (PCORI)-endorsed repository when the study is complete.