NCT05786417 LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
| NCT ID | NCT05786417 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yale University |
| Condition | Angina |
| Study Type | INTERVENTIONAL |
| Enrollment | 741 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 741 participants in total. It began in 2023-05-10 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Michael Nanna, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05786417 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Angina. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05786417 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05786417 currently recruiting?
Yes, NCT05786417 is actively recruiting participants. Contact the research team at livebetter-trial@yale.edu for enrollment information.
Where is the NCT05786417 trial being conducted?
This trial is being conducted at New Haven, United States, Marietta, United States, Chicago, United States, Boston, United States and 6 additional locations.
Who is sponsoring the NCT05786417 clinical trial?
NCT05786417 is sponsored by Yale University. The principal investigator is Michael Nanna, MD at Yale University. The trial plans to enroll 741 participants.