LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorYale University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥65 years
≥ 2 Multiple Chronic Conditions as defined by Centers for Medicare and Medicaid Services (CMS)
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
Disqualifiers
Current taking (both) a beta-blocker AND a calcium channel blocker*
significant hypotension
high grade AV block
severe symptomatic bradycardia
Trial design
Design model
Parallel
Treatments tested in this trial
Clinician Discretion
Other interventionClinician 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
DrugSelection of the specific BB and initial starting dose will be determined by the treating clinician.
Calcium channel blocker
DrugSelection of the specific CCB and initial starting dose will be determined by the treating clinician.
Treatment groups
741 Participants
are divided into 2 treatment groupsGroup A: Beta-Blockers (BB) TherapyExperimental treatment 2 interventions
Group B: Calcium Channel Blockers (CCB) TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 45 daysSecondary outcomes
1
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.
Time frame
up to 6 months2
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.
Time frame
Baseline, 6 months, 12 months, 24 months3
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.
Time frame
Baseline, 45 days, 6 months, 12 months, 24 months4
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.
Time frame
Baseline, 45 days, 6 months, 12 months, 24 monthsSponsors and contacts
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Source ClinicalTrials.gov