Back to results

South Korean Pitavastatin Heart Failure Study (SAPHIRE)

Primary Purpose

Chronic Heart Failure

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

pitavastatin

pravastatin

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring heart failure, pitavastatin, pravastatin, statin

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

SEOUL St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

strong statin

mild statin

Outcomes

Primary Outcome Measures

Rate and number of hospitalization for cardiovascular cause; Lipid profile

Secondary Outcome Measures

Biomarker : BNP, hsCRP, IL-6. TNF-α

Echocardiography : LVEF, E/A ratio, LVEDD, LVESD

Cardiac function evaluation (NYHA class distribution, 6-minute walk test)

Cardiovascular mortality

Full Information

NCT ID

NCT00701285

First Posted

June 17, 2008

Last Updated

May 12, 2014

Sponsor

JW Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00701285

Brief Title

South Korean Pitavastatin Heart Failure Study

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JW Pharmaceutical

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

Keywords

heart failure, pitavastatin, pravastatin, statin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

strong statin

Arm Title

Arm Type

Active Comparator

Arm Description

mild statin

Intervention Type

Drug

Intervention Name(s)

pitavastatin

Intervention Description

pitavastatin 4mg once daily

Intervention Type

Drug

Intervention Name(s)

pravastatin

Intervention Description

pravastatin 10mg once daily

Primary Outcome Measure Information:

Title

Rate and number of hospitalization for cardiovascular cause; Lipid profile

Time Frame

52week

Secondary Outcome Measure Information:

Title

Biomarker : BNP, hsCRP, IL-6. TNF-α

Time Frame

52 week

Title

Echocardiography : LVEF, E/A ratio, LVEDD, LVESD

Time Frame

52 week

Title

Cardiac function evaluation (NYHA class distribution, 6-minute walk test)

Time Frame

52 week

Title

Cardiovascular mortality

Time Frame

52 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang Hong Baek, MD, PhD

Organizational Affiliation

KangNam St. Mary's Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

SEOUL St. Mary's Hospital

City

Seoul

State/Province

Seocho-Ku

ZIP/Postal Code

137-040

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

25378974

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.

Results Reference

derived

Learn more about this trial

South Korean Pitavastatin Heart Failure Study

We'll reach out to this number within 24 hrs