Status:
COMPLETED
South Korean Pitavastatin Heart Failure Study
Lead Sponsor:
JW Pharmaceutical
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
30+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Patients who accepted to enter the study by written informed consent
- Age ≥ 30 years
- LDL-cholesterol ≥ 70mg/dl
- 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
- Patients who participated in other studies 3 months before enrollment
- Statin treatment within 2 months before enrollment
- Unstable decompensated heart failure at enrollment
- Acute coronary syndrome or cerebral vascular disease within 3 months before enrollment
- Coronary revascularization within 3 months before enrollment or planned at enrollment
- Any other serious disease or condition which might effect life expectancy such as malignancy, life-threatening infectious disease.
- Serum creatinine levels \>= 3.0 mg/dl
- AST or AST levels \>=2.5 times of ULN
- CK levels \>=2 times of ULN
- Uncontrolled hypothyroidism : TSH level \>= 2 times of ULN
- Pregnant or breastfeeding women, women who want to bearing
- Patients who might to be unsuitable by the decision of investigators
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00701285
Start Date
July 1 2008
End Date
May 1 2014
Last Update
May 14 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SEOUL St. Mary's Hospital
Seoul, Seocho-Ku, South Korea, 137-040