South Korean Pitavastatin Heart Failure Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

strong statin

Group Type ACTIVE_COMPARATOR

pitavastatin

Intervention Type DRUG

pitavastatin 4mg once daily

2

mild statin

Group Type ACTIVE_COMPARATOR

pravastatin

Intervention Type DRUG

pravastatin 10mg once daily

Interventions

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pitavastatin

pitavastatin 4mg once daily

Intervention Type DRUG

pravastatin

pravastatin 10mg once daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No