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| ID | Type | Description | Link |
|---|---|---|---|
| HA-2021C3-24767 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) | |
| K76AG088428 | U.S. NIH Grant/Contract | View source |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-Blockers (BB) Therapy | Experimental | 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). |
|
| Calcium Channel Blockers (CCB) Therapy | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician Discretion | Other | Clinician discretion as to which BB or CCB will be used if the participant has a heart rate and blood pressure within normal limits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 months |
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Inclusion Criteria:
OLDER ADULTS WITH SIHD AND MCC
Age ā„65 years
ā„ 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 ā„70% in a coronary artery ā„2 mm in diameter or
ā„50% stenosis of left main
Invasive coronary angiography with positive physiologic testing in at least one vessel (FFR ⤠0.80 or iFR ā¤0.89)
CAREGIVERS
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:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Nanna, MD | Contact | (888) 683-0865 | livebetter-trial@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Nanna, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | Recruiting | New Haven | Connecticut | 06520 | United States | |
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.
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Single-blind, randomized (1:1), 640 Older Adults with SIHD and MCC and 101 caregivers
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| Beta blocker | Drug | Selection of the specific BB and initial starting dose will be determined by the treating clinician. |
|
| Calcium channel blocker | Drug | Selection of the specific CCB and initial starting dose will be determined by the treating clinician. |
|
| 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, 6 months, 12 months, 24 months |
| Change in Quality of Life assessed using PROMISĀ® 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. | 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. | 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. | 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. | Baseline, 45 days, 6 months, 12 months, 24 months |
| Wellstar Research Institute |
| Recruiting |
| Marietta |
| Georgia |
| 30060 |
| United States |
| Cook County Health | Recruiting | Chicago | Illinois | 60612 | United States |
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Mt. Sinai Health System | Recruiting | New York | New York | 10029 | United States |
| NYC Health and Hospitals, Harlem Hospital | Not yet recruiting | New York | New York | 10037-1802 | United States |
| Nirvana Integrative Medicine | Recruiting | New York | New York | 10469 | United States |
| Duke University, School of Medicine | Recruiting | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
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| Inova Health Care Services | Recruiting | Fairfax | Virginia | 22033 | United States |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000319 | Adrenergic beta-Antagonists |
| D002121 | Calcium Channel Blockers |
| ID | Term |
|---|---|
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D049990 | Membrane Transport Modulators |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
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