South Korean Pitavastatin Heart Failure Study (SAPHIRE)

JW Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Chronic Heart Failure

Treatments: Drug: pravastatin; Drug: pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701285

CWP-PTV-703

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

1

Active Comparator group

Description:

strong statin

Treatment:

Drug: pitavastatin

2

Active Comparator group

Description:

mild statin

Treatment:

Drug: pravastatin