Clinical trial NCT00701285: South Korean Pitavastatin Heart Failure Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure
Keywords: heart failure
pitavastatin
pravastatin
statin
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate and number of hospitalization for cardiovascular cause; Lipid profile
timeFrame: 52week
Secondary outcomes:
measure: Biomarker : BNP, hsCRP, IL-6. TNF-α
timeFrame: 52 week
measure: Echocardiography : LVEF, E/A ratio, LVEDD, LVESD
timeFrame: 52 week
measure: Cardiac function evaluation (NYHA class distribution, 6-minute walk test)
timeFrame: 52 week
measure: Cardiovascular mortality
timeFrame: 52 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SEOUL St. Mary's Hospital
state: Seocho-Ku
Study officials:
affiliation: KangNam St. Mary's Hospital
name: Sang Hong Baek, MD, PhD
role: STUDY_CHAIR
References:
citation: Lee HY, Cho HJ, Kim HY, Jeon HK, Shin JH, Kang SM, Baek SH. Effects of intensive versus mild lipid lowering by statins in patients with ischemic congestive heart failure: Korean Pitavastatin Heart Failure (SAPHIRE) study. Korean J Intern Med. 2014 Nov;29(6):754-63. doi: 10.3904/kjim.2014.29.6.754. Epub 2014 Oct 31.