RECRUITING

LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions

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Conditions

AnginaStable Ischemic Heart Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Trial Comparing the Effectiveness and Tolerability of Medications in Older Adults With Stable Angina and Multiple Chronic Conditions: LIVEBETTER

Quick Facts

Study Start:2023-05-10
Study Completion:2027-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05786417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥70 years; ≥65 years for underrepresented minorities (URM) of black race or Hispanic ethnicity
  2. * ≥ 2 Multiple Chronic Conditions as defined by Centers for Medicare and Medicaid Services (CMS)
  3. * Diagnosis of Symptomatic Stable Ischemic Heart Disease with plans to initiate medical therapy identified by at least one of the following:
  4. 1. positive non-invasive functional or anatomic testing suggestive of obstructive coronary artery disease
  5. 2. coronary angiography with stenosis ≥70% in a coronary artery ≥2 mm in diameter or
  6. 3. Invasive coronary angiography with positive physiologic testing in at least one vessel (FFR ≤ 0.80 or iFR ≤0.89)
  7. * Age ≥ 18 years
  8. * Identified as caregiver of LIVEBETTER participant
  1. * Current taking beta-blocker or calcium channel blocker\*
  2. * Contraindication to beta-blockers or calcium channel blockers including:
  3. 1. significant hypotension
  4. 2. high grade AV block
  5. 3. severe symptomatic bradycardia
  6. 4. severe obstructive lung disease
  7. * Documented intolerance to beta-blockers or calcium channel blockers
  8. * 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
  9. * Plans for complete revascularization within 2 weeks
  10. * Clear indication for beta-blockers or calcium channel blockers including:
  11. 1. Diagnosis of acute coronary syndrome (ACS) with reduced ejection fraction within past year
  12. 2. Heart failure with reduced ejection fraction (HFrEF) within past year
  13. * Actively participating in another clinical trial involving an investigational medication or device
  14. * Primary language other than English or Spanish
  15. * Inability to complete follow-up (e.g. life expectancy \<12 months, impaired decision-making determined by validated instrument)
  16. * Previously enrolled in LIVEBETTER
  17. * Refused informed consent
  18. * Professional caregiver (i.e. not a relative or close friend of the participant)
  19. * Primary language other than English or Spanish
  20. * Inability to complete follow-up
  21. * Previously enrolled in LIVEBETTER
  22. * Refused informed consent

Contacts and Locations

Study Contact

Michael Nanna, MD
CONTACT
(888) 683-0865
livebetter-trial@yale.edu

Principal Investigator

Michael Nanna, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale School of Medicine
New Haven, Connecticut, 06520
United States
Wellstar Research Institute
Marietta, Georgia, 30060
United States
Cook County Health
Chicago, Illinois, 60612
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Mt. Sinai Health System
New York, New York, 10029
United States
NYC Health and Hospitals, Harlem Hospital
New York, New York, 10037-1802
United States
Nirvana Integrative Medicine
New York, New York, 10469
United States
Duke University, School of Medicine
Durham, North Carolina, 27710
United States
Inova Health Care Services
Fairfax, Virginia, 22033
United States

Collaborators and Investigators

Sponsor: Yale University

  • Michael Nanna, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-10
Study Completion Date2027-05-30

Study Record Updates

Study Start Date2023-05-10
Study Completion Date2027-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Angina
  • Stable Ischemic Heart Disease