Идёт набор NCT05786417

LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions

Фаза IV С лечением Angina Stable Ischemic Heart Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Clinician Discretion, Beta blocker, Calcium channel blocker.
Кому может быть актуально: Состояния в реестре: Angina, Stable Ischemic Heart Disease. Базовые параметры: от 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER

Обзор

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).

Подробное описание

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.

Вмешательства

Другое 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.
Препарат Beta blocker
Selection of the specific BB and initial starting dose will be determined by the treating clinician.
Препарат Calcium channel blocker
Selection of the specific CCB and initial starting dose will be determined by the treating clinician.

Первичные конечные точки

Change in Quality of Life assessed using EQ-5D-5L [Срок оценки: Baseline and 45 days]

Вторичные конечные точки (6)

Change in Persistence on medication [Срок оценки: up to 6 months]
Change in Quality of Life assessed using EQ-5D-5L [Срок оценки: Baseline, 6 months, 12 months, 24 months]
Change in Quality of Life assessed using PROMIS® Scale v1.2 - Global Health [Срок оценки: Baseline, 45 days, 6 months, 12 months, 24 months]
Change in Angina Control assessed using Seattle Angina Questionnaire (SAQ) Summary Score [Срок оценки: Baseline, 45 days, 6 months, 12 months, 24 months]
Change in 6-minute walk test [Срок оценки: Baseline and 45 days]
Change in Caregiver Burden Inventory [Срок оценки: Baseline, 45 days, 6 months, 12 months, 24 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

CAREGIVERS