- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00701285
South Korean Pitavastatin Heart Failure Study (SAPHIRE)
May 12, 2014 updated by: JW Pharmaceutical
A Prospective, Randomized, Two Group Comparison Study to Evaluate the Effect of Statin on Heart Function in Patients With Chronic Ischemic Heart Failure.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seocho-Ku
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Seoul, Seocho-Ku, Korea, Republic of, 137-040
- Seoul St. Mary's hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
strong statin
|
pitavastatin 4mg once daily
|
Active Comparator: 2
mild statin
|
pravastatin 10mg once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate and number of hospitalization for cardiovascular cause; Lipid profile
Time Frame: 52week
|
52week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biomarker : BNP, hsCRP, IL-6. TNF-α
Time Frame: 52 week
|
52 week
|
Echocardiography : LVEF, E/A ratio, LVEDD, LVESD
Time Frame: 52 week
|
52 week
|
Cardiac function evaluation (NYHA class distribution, 6-minute walk test)
Time Frame: 52 week
|
52 week
|
Cardiovascular mortality
Time Frame: 52 week
|
52 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sang Hong Baek, MD, PhD, KangNam St. Mary's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
June 17, 2008
First Submitted That Met QC Criteria
June 18, 2008
First Posted (Estimate)
June 19, 2008
Study Record Updates
Last Update Posted (Estimate)
May 14, 2014
Last Update Submitted That Met QC Criteria
May 12, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CWP-PTV-703
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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