Coronary Artery Disease
Conditions
Brief summary
1. OBJECTIVES Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max, mL/kg/min) in amlodipine group against no CCB group at 9 months Secondary objectives To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at 9 months 2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea
Interventions
DRUGPlacebo
Placebo
DRUGAmlodipine
Amlodipine
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Stable angina patient with angiographically confirmed significant residual stenosis * Stenosis more than 50% in 2 major coronary arteries at least or Stenosis more than 75% in 1 major coronary artery
Exclusion criteria
* No other pulmonary/psychiatry/musculoskeletal disorder limiting CPET * Contraindicated to the CPET (e.g. unstable angina, aortic stenosis, uncontrolled hypertension, uncontrolled asthma, hypoxemia at rest, epilepsy, locomotor disorder, severe hypertension and febrile illness)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | 9 months | Difference of the peak oxygen uptake change (VO2 max, mL/kg/min) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sublingual Nitrate | 1month and 3 months | To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months |
| Biomarkers | 9 months | To evaluate the change of biomarkers against no CCB group at 9 months |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORHyo-Soo Kim, MD, PhD
Seoul National University Hospital
Outcome results
None listed