South Korean Pitavastatin Heart Failure Study

Chronic Heart Failure Clinical Trial

— SAPHIRE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701285
• Other study ID #: CWP-PTV-703
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2008
• Last updated: May 12, 2014
• Start date: July 2008
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• pitavastatin
pitavastatin 4mg once daily
• pravastatin
pravastatin 10mg once daily

Locations

Country	Name	City	State
Korea, Republic of	SEOUL St. Mary's Hospital	Seoul	Seocho-Ku

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and number of hospitalization for cardiovascular cause; Lipid profile		52week	Yes
Secondary	Biomarker : BNP, hsCRP, IL-6. TNF-a		52 week	Yes
Secondary	Echocardiography : LVEF, E/A ratio, LVEDD, LVESD		52 week	Yes
Secondary	Cardiac function evaluation (NYHA class distribution, 6-minute walk test)		52 week	Yes
Secondary	Cardiovascular mortality		52 week	Yes