Recruiting

Medications

Sponsor:

Yale University

Code:

NCT05786417

Conditions

Angina

Stable Ischemic Heart Disease

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Clinician Discretion

Beta blocker

Calcium channel blocker

Study Details

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).

Conditions

Angina

Stable Ischemic Heart Disease

Study ID

NCT05786417

Start date

May 10, 2023

Status verified date

Apr, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

741 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Beta-Blockers (BB) Therapy

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).

experimental: Calcium Channel Blockers (CCB) Therapy

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).

Interventions

Clinician Discretion

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 blocker

Selection of the specific BB and initial starting dose will be determined by the treating clinician.

Calcium channel blocker

Selection of the specific CCB and initial starting dose will be determined by the treating clinician.

Primary outcome measure

  • Change in Quality of Life assessed using EQ-5D-5L [ Time Frame: Baseline and 45 days ]

Central Contacts and Locations

Central contacts

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

Wellstar Research Institute

Recruiting

Marietta, Georgia, United States, 30060

Cook County Health

Recruiting

Chicago, Illinois, United States, 60612

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Mt. Sinai Health System

Recruiting

New York, New York, United States, 10029

Nirvana Integrative Medicine

Recruiting

New York, New York, United States, 10469

Duke University, School of Medicine

Recruiting

Durham, North Carolina, United States, 27710

Inova Health Care Services

Recruiting

Fairfax, Virginia, United States, 22033

More Information

Sponsor

Yale University

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-04-07.