Chronic Heart FailurePhase 4SAPHIRENCT00701285
South Korean Pitavastatin Heart Failure Study
A Phase 4 study testing pitavastatin and pravastatin in people with Chronic Heart Failure, run by JW Pharmaceutical at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- pitavastatin and pravastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
- Conditions
- Chronic Heart Failure
- Being tested
- pitavastatin, pravastatin
- Keywords
- heart failure, pitavastatin, pravastatin, statin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pitavastatinDrug
pitavastatin 4mg once daily
pravastatinDrug
pravastatin 10mg once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | strong statin Receives: Drug: pitavastatin |
| 2 | Active comparator | mild statin Receives: Drug: pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and number of hospitalization for cardiovascular cause; Lipid profile
Measured: 52week
Secondary outcomes (4)
Biomarker : BNP, hsCRP, IL-6. TNF-α
Measured: 52 week
Echocardiography : LVEF, E/A ratio, LVEDD, LVESD
Measured: 52 week
Cardiac function evaluation (NYHA class distribution, 6-minute walk test)
Measured: 52 week
Cardiovascular mortality
Measured: 52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Hong Baek, MD, PhD, Study chair, KangNam St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701285
- Sponsor's protocol ID
- CWP-PTV-703
- Acronym
- SAPHIRE
- Status last verified
- May 2014
- First submitted
- 17 Jun 2008
- Last updated
- 14 May 2014
- Results posted
- No
Publications
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.
PubMed 25378974
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00701285
- Acronym / sponsor ID
- SAPHIRE / CWP-PTV-703
- Conditions
- Chronic Heart Failure
- Keywords
- heart failure, pitavastatin, pravastatin, statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: pitavastatinstrong statin |
| 2 | Active comparator | Drug: pravastatinmild statin |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who accepted to enter the study by written informed consent
- Age ≥ 30 years
- LDL-cholesterol ≥ 70mg/dl
- Chronic heart failure of :
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pitavastatinpitavastatin 4mg once daily | Drug | 1 |
| pravastatinpravastatin 10mg once daily | Drug | 2 |
Primary outcome
Rate and number of hospitalization for cardiovascular cause; Lipid profile
Time frame: 52week
4 secondary outcomes
Biomarker : BNP, hsCRP, IL-6. TNF-α
Time frame: 52 week
Echocardiography : LVEF, E/A ratio, LVEDD, LVESD
Time frame: 52 week
Cardiac function evaluation (NYHA class distribution, 6-minute walk test)
Time frame: 52 week
Cardiovascular mortality
Time frame: 52 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
- Derived from this study: PubMed 25378974Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Hong Baek, MD, PhD study chair
KangNam St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pitavastatin and pravastatin in people with Chronic Heart Failure, run by JW Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and number of hospitalization for cardiovascular cause; Lipid profile (time frame: 52week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00701285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.