Comparing medications for older adults with stable angina and multiple chronic conditions
A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER
This study is testing whether standard heart medications, like beta-blockers and calcium channel blockers, can help older adults with stable angina and other health issues feel better and improve their quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 741 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 10 sites (New Haven, Connecticut and 9 other locations) |
| Trial ID | NCT05786417 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and tolerability of standard anti-anginal treatments, specifically beta-blockers and calcium channel blockers, in older adults suffering from symptomatic Stable Ischemic Heart Disease (SIHD) and multiple chronic conditions. It is a single-blind, randomized trial that aims to improve symptoms, function, and quality of life over a 12-month period through four study visits that include interviews, a six-minute walk test, and medical record reviews. The study will also assess the safety and long-term effectiveness of these medications, providing valuable data to inform clinical practice and guidelines.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 70 and above, or 65 and above for underrepresented minorities, with symptomatic Stable Ischemic Heart Disease and at least two chronic conditions.
Not a fit: Patients currently taking beta-blockers or calcium channel blockers, or those with contraindications to these medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and quality of life for older adults with stable angina and multiple chronic conditions.
How similar studies have performed: Other studies have shown success in comparing anti-anginal medications, but this trial aims to fill specific gaps in evidence for older adults with multiple chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
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:
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 (both) a beta-blocker AND a 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 clinical indication for beta-blockers or calcium channel blockers that precludes dose adjustment or crossover:
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
Where this trial is running
New Haven, Connecticut and 9 other locations
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
- Wellstar Research Institute — Marietta, Georgia, United States (Recruiting)
- Cook County Health — Chicago, Illinois, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Mt. Sinai Health System — New York, New York, United States (Recruiting)
- NYC Health and Hospitals, Harlem Hospital — New York, New York, United States (Not_yet_recruiting)
- Nirvana Integrative Medicine — New York, New York, United States (Recruiting)
- Duke University, School of Medicine — Durham, North Carolina, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
- Inova Health Care Services — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Michael Nanna, MD — Yale University
- Study coordinator: Michael Nanna, MD
- Email: livebetter-trial@yale.edu
- Phone: (888) 683-0865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.