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Completed

NCT Number: NCT00701285

South Korean Pitavastatin Heart Failure Study

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.

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Key information

Conditions

Chronic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SEOUL St. Mary's Hospital

Seoul, Seocho-Ku, 137-040, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pitavastatin

Drug

pitavastatin 4mg once daily

Pravastatin

Drug

pravastatin 10mg once daily

Primary outcomes

  1. Rate and number of hospitalization for cardiovascular cause; Lipid profile

    Time frame: 52week

Secondary outcomes

  1. Biomarker : BNP, hsCRP, IL-6. TNF-α

    Time frame: 52 week

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

    Time frame: 52 week

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

    Time frame: 52 week

  4. Cardiovascular mortality

    Time frame: 52 week

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Prospective, Randomized, Two Group Comparison Study to Evaluate the Effect of Statin on Heart Function in Patients With Chronic Ischemic Heart Failure.

Acronym: SAPHIRE

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Jun 19, 2008
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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