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).
Single-blind, randomized (1:1) pragmatic trial comparing Beta-Blocker therapy versus Calcium Channel Blocker therapy in older adults with symptomatic SIHD and MCC with plans to initiate medical treatment with anti-anginal therapy. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
741
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.
Yale School of Medicine
New Haven, Connecticut, United States
RECRUITINGWellstar Research Institute
Marietta, Georgia, United States
RECRUITINGChange 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.
Time frame: Baseline and 45 days
Change in Persistence on medication
Persistence on anti-anginal medication in the assigned treatment arm, as verified through a combination of the medical records (medication administration) and through self-report. Persistence is defined as either "Persistent" on treatment or "Not persistent" on treatment.
Time frame: up to 6 months
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.
Time frame: Baseline, 6 months, 12 months, 24 months
Change in Quality of Life assessed using PROMIS® Scale v1.2 - Global Health
The PROMIS Scale measures Physical Function (PF), Pain Interference (PI) and Anxiety Components with T - Score = 50 = General Population Mean. A Score \> 50 = Better Physical Function, Less anxiety and decreased pain A Score \< 50 = Poor Physical Function, More anxiety, and increased pain.
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Cook County Health
Chicago, Illinois, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGMt. Sinai Health System
New York, New York, United States
RECRUITINGNYC Health and Hospitals, Harlem Hospital
New York, New York, United States
NOT_YET_RECRUITINGNirvana Integrative Medicine
New York, New York, United States
RECRUITINGDuke University, School of Medicine
Durham, North Carolina, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
NOT_YET_RECRUITINGInova Health Care Services
Fairfax, Virginia, United States
RECRUITINGTime frame: Baseline, 45 days, 6 months, 12 months, 24 months
Change in Angina Control assessed using Seattle Angina Questionnaire (SAQ) Summary Score
The 7-item SAQ instrument captures the frequency of angina with the SAQ Angina Frequency score (and conversely "freedom from angina"), disease-specific effect of angina on physical function with the SAQ Physical Limitation score and quality of life with the Quality of Life score; these scores average to the SAQ Summary score. The scale of the score ranges from 0 - 100. 0 to 24 represents poor health status, 25 to 49 as fair, 50 to 74 as good, and 75 to 100 as excellent.
Time frame: Baseline, 45 days, 6 months, 12 months, 24 months
Change in 6-minute walk test
The 6-minute walk test provides a more objective quantitative measure of mobility, functional performance, and symptom control. It measures the distance an individual can walk over a total of six minutes on a hard, flat surface. The individual can self-pace and rest as needed as they walk back and forth along a marked course. The participant can use an assistive walking device they normally use, such as a cane. The minimum clinically important difference in 6-minute walk distance is approximately 30 meters, a difference that is associated with mortality.
Time frame: Baseline and 45 days
Change in Caregiver Burden Inventory
24-item questionnaire measuring caregiver burden with 5 subscales: (a) Time Dependence; (b) Developmental; (c) Behavior; (d) Physical Burden; (e) Social Burden; (f) Emotional Burden. This measure will provide insight into the degree to which treatment with different anti-anginal therapies impacts caregiver burden. Scores from subscales are summed for total score. The maximum score (maximum burden) is 96, with a minimum possible score of 0. A total score \>36 indicates a risk of caregiver burnout whereas scores near or slightly \>24 indicate a need to seek respite care.
Time frame: Baseline, 45 days, 6 months, 12 months, 24 months