Chronic Heart Failure
Conditions
Keywords
heart failure, pitavastatin, pravastatin, statin
Brief summary
We want to evaluate the utility of statins on heart function according to potency. Patients with chronic ischemic heart failure are administered pitavastatin 4mg or pravastatin 10mg for 52 weeks. Then we evaluate the effect of pitavastatin and pravastatin primarily on rate of hospitalization for cardiovascular cause and lipid profile secondarily biomarker, echocardiography parameter, 6-minute walk, change of NYHA class distribution, cardiovascular mortality.
Interventions
DRUGpitavastatin
pitavastatin 4mg once daily
DRUGpravastatin
pravastatin 10mg once daily
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who accepted to enter the study by written informed consent 2. Age ≥ 30 years 3. LDL-cholesterol ≥ 70mg/dl 4. Chronic heart failure of : * NYHA class II \ III * Ischemic etiology * Left ventricular ejection fraction \< 45% * Optimal therapy for chronic heart failure and stable clinical condition over the two weeks.
Exclusion criteria
1. Patients who participated in other studies 3 months before enrollment 2. Statin treatment within 2 months before enrollment 3. Unstable decompensated heart failure at enrollment 4. Acute coronary syndrome or cerebral vascular disease within 3 months before enrollment 5. Coronary revascularization within 3 months before enrollment or planned at enrollment 6. Any other serious disease or condition which might effect life expectancy such as malignancy, life-threatening infectious disease. 7. Serum creatinine levels \>= 3.0 mg/dl 8. AST or AST levels \>=2.5 times of ULN 9. CK levels \>=2 times of ULN 10. Uncontrolled hypothyroidism : TSH level \>= 2 times of ULN 11. Pregnant or breastfeeding women, women who want to bearing 12. Patients who might to be unsuitable by the decision of investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate and number of hospitalization for cardiovascular cause; Lipid profile | 52week |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality | 52 week |
| Echocardiography : LVEF, E/A ratio, LVEDD, LVESD | 52 week |
| Cardiac function evaluation (NYHA class distribution, 6-minute walk test) | 52 week |
| Biomarker : BNP, hsCRP, IL-6. TNF-α | 52 week |
Countries
South Korea
Outcome results
None listed