South Korean Pitavastatin Heart Failure Study (SAPHIRE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by JW Pharmaceutical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00701285
First received: June 17, 2008
Last updated: October 4, 2012
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Chronic Heart Failure
Drug: pitavastatin
Drug: pravastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Rate and number of hospitalization for cardiovascular cause; Lipid profile [ Time Frame: 52week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biomarker : BNP, hsCRP, IL-6. TNF-α [ Time Frame: 52 week ] [ Designated as safety issue: Yes ]
  • Echocardiography : LVEF, E/A ratio, LVEDD, LVESD [ Time Frame: 52 week ] [ Designated as safety issue: Yes ]
  • Cardiac function evaluation (NYHA class distribution, 6-minute walk test) [ Time Frame: 52 week ] [ Designated as safety issue: Yes ]
  • Cardiovascular mortality [ Time Frame: 52 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: July 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
strong statin
Drug: pitavastatin
pitavastatin 4mg once daily
Active Comparator: 2
mild statin
Drug: pravastatin
pravastatin 10mg once daily

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701285

Locations
Korea, Republic of
SEOUL St. Mary's Hospital
Seoul, Seocho-Ku, Korea, Republic of, 137-040
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Study Chair: Sang Hong Baek, MD, PhD KangNam St. Mary's Hospital
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00701285     History of Changes
Other Study ID Numbers: CWP-PTV-703
Study First Received: June 17, 2008
Last Updated: October 4, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by JW Pharmaceutical:
heart failure
pitavastatin
pravastatin
statin

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pravastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014