AnginaPhase 4LIVEBETTERNCT05786417
LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
A Phase 4 study testing Clinician Discretion, Beta blocker and Calcium channel blocker in people with Angina and Stable Ischemic Heart Disease, run by Yale University at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Angina, Stable Ischemic Heart Disease
- What is being tested?
- Clinician Discretion, Beta blocker and Calcium channel blocker
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 741 participants
- Where
- 10 sitesUnited States
- Study dates
- 10 May 2023to 30 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 11Show fewer
- ≥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
Who cannot join
- 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
Show all 24Show fewer
- 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
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Cook County Health
Chicago, Illinois, 60612
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Abdulla Damluji, MD, 216-630-3297
- Recruiting
Duke University, School of Medicine
Durham, North Carolina, 27710
- Recruiting
Inova Health Care Services
Fairfax, Virginia, 22033
- Recruiting
Wellstar Research Institute
Marietta, Georgia, 30060
- Recruiting
Yale School of Medicine
New Haven, Connecticut, 06520
- Recruiting
Mt. Sinai Health System
New York, New York, 10029
- Not yet recruiting
NYC Health and Hospitals, Harlem Hospital
New York, New York, 10037-1802
- Recruiting
Nirvana Integrative Medicine
New York, New York, 10469
About this study
Official title: A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER
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).
Read the 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:
- 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.
- Conditions
- Angina, Stable Ischemic Heart Disease
- Being tested
- Clinician Discretion, Beta blocker, Calcium channel blocker
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician DiscretionOther
Clinician discretion as to which BB or CCB will be used if the participant has a heart rate and blood pressure within normal limits.
Beta blockerDrug
Selection of the specific BB and initial starting dose will be determined by the treating clinician.
Calcium channel blockerDrug
Selection of the specific CCB and initial starting dose will be determined by the treating clinician.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Clinician Discretion; Drug: Beta blocker |
| 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). Receives: Other: Clinician Discretion; Drug: Calcium channel blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 45 days
Secondary outcomes (6)
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.
Measured: up to 6 months
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.
Measured: Baseline, 6 months, 12 months, 24 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 45 days, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start10 May 2023
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnginaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, randomized (1:1), 640 Older Adults with SIHD and MCC and 101 caregivers
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 741 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Nanna, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786417
- Sponsor's protocol ID
- 2000034470
- Other IDs
- HA-2021C3-24767, K76AG088428
- Acronym
- LIVEBETTER
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER
- ClinicalTrials.gov ID
- NCT05786417
- Acronym / sponsor ID
- LIVEBETTER / 2000034470
- Conditions
- Angina, Stable Ischemic Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 741 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, randomized (1:1), 640 Older Adults with SIHD and MCC and 101 caregivers
| Arm | Type | Receives |
|---|---|---|
| Beta-Blockers (BB) Therapy | Experimental | Other: Clinician Discretion, Drug: Beta blockerParticipants 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 | Other: Clinician Discretion, Drug: Calcium channel blockerParticipants 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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:
- ≥50% stenosis of left main
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician DiscretionClinician discretion as to which BB or CCB will be used if the participant has a heart rate and blood pressure within normal limits. | Other | Beta-Blockers (BB) Therapy, Calcium Channel Blockers (CCB) Therapy |
| Beta blockerSelection of the specific BB and initial starting dose will be determined by the treating clinician. | Drug | Beta-Blockers (BB) Therapy |
| Calcium channel blockerSelection of the specific CCB and initial starting dose will be determined by the treating clinician. | Drug | Calcium Channel Blockers (CCB) Therapy |
Primary outcome
Change in Quality of Life assessed using EQ-5D-5L
Time frame: 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.
6 secondary outcomes
Change in Persistence on medication
Time frame: up to 6 months
Change in Quality of Life assessed using EQ-5D-5L
Time frame: Baseline, 6 months, 12 months, 24 months
Change in Quality of Life assessed using PROMIS® Scale v1.2 - Global Health
Time frame: Baseline, 45 days, 6 months, 12 months, 24 months
Change in Angina Control assessed using Seattle Angina Questionnaire (SAQ) Summary Score
Time frame: Baseline, 45 days, 6 months, 12 months, 24 months
Change in 6-minute walk test
Time frame: Baseline and 45 days
Change in Caregiver Burden Inventory
Time frame: Baseline, 45 days, 6 months, 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Nanna, MD principal investigator
Yale University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clinician Discretion, Beta blocker and Calcium channel blocker in people with Angina and Stable Ischemic Heart Disease, run by Yale University at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Nanna, MD ((888) 683-0865, livebetter-trial@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life assessed using EQ-5D-5L (time frame: Baseline and 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.