SAPHIRE: South Korean Pitavastatin Heart Failure Study

Sponsor

JW Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00701285

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Drug: pitavastatin Drug: pravastatin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Two Group Comparison Study to Evaluate the Effect of Statin on Heart Function in Patients With Chronic Ischemic Heart Failure.

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 strong statin	Drug: pitavastatin pitavastatin 4mg once daily
Active Comparator: 2 mild statin	Drug: pravastatin pravastatin 10mg once daily

Arm

Intervention/Treatment

Active Comparator: 1

strong statin

Drug: pitavastatin

pitavastatin 4mg once daily

Active Comparator: 2

mild statin

Drug: pravastatin

pravastatin 10mg once daily

Outcome Measures

Primary Outcome Measures

Rate and number of hospitalization for cardiovascular cause; Lipid profile [52week]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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