A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 741
- 试验地点
- 9
- 主要终点
- Change in Quality of Life assessed using EQ-5D-5L
研究概览
简要总结
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).
详细描述
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:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Age ≥ 18 years
- •Identified as caregiver of LIVEBETTER participant
排除标准
- •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
- •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
- •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
研究组 & 干预措施
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).
干预措施: Clinician Discretion (Other)
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).
干预措施: Beta blocker (Drug)
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).
干预措施: Clinician Discretion (Other)
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).
干预措施: Calcium channel blocker (Drug)
结局指标
主要结局
Change in Quality of Life assessed using EQ-5D-5L
时间窗: Baseline and 45 days
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.
次要结局
- 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)
- Change in Caregiver Burden Inventory(Baseline, 45 days, 6 months, 12 months, 24 months)