Back to resultsA Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions (LIVEBETTER)
Primary Purpose
Angina, Stable Ischemic Heart Disease
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clinician Discretion
Beta blocker
Calcium channel blocker
Sponsored by
About this trial
This is an interventional supportive care trial for Angina
Eligibility Criteria
Inclusion Criteria: OLDER ADULTS WITH SIHD AND MCC Age ≥ 75 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 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: 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 indication for beta-blockers or calcium channel blockers including: Diagnosis of acute coronary syndrome (ACS) 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 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
Sites / Locations
- Kaiser Permanente Division of Research
- Yale School of MedicineRecruiting
- Brigham and Women's Hospital
- Duke University, School of Medicine
- Inova Health Care Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Beta-Blockers (BB) Therapy
Calcium Channel Blockers (CCB) Therapy
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05786417
Brief Title
A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
Acronym
LIVEBETTER
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
May 30, 2027 (Anticipated)
Study Completion Date
May 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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 (≥75 years) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina, Stable Ischemic Heart Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, randomized (1:1), 500 Older Adults with SIHD and MCC and 250 caregivers
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beta-Blockers (BB) Therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Calcium Channel Blockers (CCB) Therapy
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Clinician Discretion
Intervention Description
Clinician discretion as to which BB or CCB will be used if the participant has a heart rate and blood pressure within normal limits.
Intervention Type
Drug
Intervention Name(s)
Beta blocker
Intervention Description
Selection of the specific BB and initial starting dose will be determined by the treating clinician.
Intervention Type
Drug
Intervention Name(s)
Calcium channel blocker
Intervention Description
Selection of the specific CCB and initial starting dose will be determined by the treating clinician.
Primary Outcome Measure Information:
Title
Change in Quality of Life assessed using EQ-5D-5L
Description
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
Secondary Outcome Measure Information:
Title
Change in Persistence on medication
Description
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
Title
Change in Quality of Life assessed using EQ-5D-5L
Description
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 and 12 months
Title
Change in Quality of Life assessed using PROMIS® Scale v1.2 - Global Health
Description
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.
Time Frame
Baseline, 45 days, 6 months and 12 months
Title
Change in Angina Control assessed using Seattle Angina Questionnaire (SAQ) Summary Score
Description
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 and 12 months
Title
Change in 6-minute walk test
Description
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
Title
Change in Caregiver Burden Inventory
Description
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 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OLDER ADULTS WITH SIHD AND MCC
Age ≥ 75 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
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:
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 indication for beta-blockers or calcium channel blockers including:
Diagnosis of acute coronary syndrome (ACS) 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Nanna, MD
Phone
(888) 683-0865
Email
livebetter-trial@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Nanna, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Division of Research
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Duke University, School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Inova Health Care Services
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Learn more about this trial
A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
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