South Korean Pitavastatin Heart Failure Study

Phase 4

Completed

• Conditions: Chronic Heart Failure
• Interventions: Drug: pitavastatin; Drug: pravastatin

• Registration Number: NCT00701285
• Lead Sponsor: JW Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Study Start: 2008-07
• Primary Completion: 2013-05
• Status Verified: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	pitavastatin	strong statin
2	pravastatin	mild statin

Primary Outcome Measures

Name	Time	Method
Rate and number of hospitalization for cardiovascular cause; Lipid profile	52week

Secondary Outcome Measures

Name	Time	Method
Biomarker : BNP, hsCRP, IL-6. TNF-α	52 week
Echocardiography : LVEF, E/A ratio, LVEDD, LVESD	52 week
Cardiac function evaluation (NYHA class distribution, 6-minute walk test)	52 week
Cardiovascular mortality	52 week

Trial Locations

Locations (1)

SEOUL St. Mary's Hospital; 🇰🇷 Seoul, Seocho-Ku, Korea, Republic of