Clinical trial NCT05786417: LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
Official title: A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Angina
Stable Ischemic Heart Disease
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 960
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, randomized (1:1), 640 Older Adults with SIHD and MCC and 320 caregivers
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

OLDER ADULTS WITH SIHD AND MCC

* Age ≥70 years; ≥65 years for underrepresented minorities (URM) of black race or Hispanic ethnicity
* ≥ 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:

  1. positive non-invasive functional or anatomic testing suggestive of obstructive coronary artery disease
  2. coronary angiography with stenosis ≥70% in a coronary artery ≥2 mm in diameter or

     ≥50% stenosis of left main
  3. 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

Exclusion Criteria:

OLDER ADULTS WITH SIHD AND MCC

* Current taking beta-blocker or calcium channel blocker\*
* Contraindication to beta-blockers or calcium channel blockers including:

  1. significant hypotension
  2. high grade AV block
  3. severe symptomatic bradycardia
  4. 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 indication for beta-blockers or calcium channel blockers including:

  1. Diagnosis of acute coronary syndrome (ACS) with reduced ejection fraction within past year
  2. 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

* 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

Primary outcomes:
measure: Change in Quality of Life assessed using EQ-5D-5L
timeFrame: Baseline and 45 days
Secondary outcomes:
measure: Change in Persistence on medication
timeFrame: up to 6 months
measure: Change in Quality of Life assessed using EQ-5D-5L
timeFrame: Baseline, 6 months and 12 months
measure: Change in Quality of Life assessed using PROMIS® Scale v1.2 - Global Health
timeFrame: Baseline, 45 days, 6 months and 12 months
measure: Change in Angina Control assessed using Seattle Angina Questionnaire (SAQ) Summary Score
timeFrame: Baseline, 45 days, 6 months and 12 months
measure: Change in 6-minute walk test
timeFrame: Baseline and 45 days
measure: Change in Caregiver Burden Inventory
timeFrame: Baseline, 45 days, 6 months and 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Marietta
country: United States
facility: Wellstar Research Institute
state: Georgia
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Mt. Sinai Health System
state: New York
city: New York
country: United States
facility: NYC Health and Hospitals, Harlem Hospital
state: New York
city: New York
country: United States
facility: Nirvana Integrative Medicine
state: New York
city: Durham
country: United States
facility: Duke University, School of Medicine
state: North Carolina
city: Fairfax
country: United States
facility: Inova Health Care Services
state: Virginia
Study officials:
affiliation: Yale University
name: Michael Nanna, MD
role: PRINCIPAL_INVESTIGATOR
References: