NCT00701285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

4.8 years

First QC Date

June 17, 2008

Last Update Submit

May 12, 2014

Conditions

Chronic Heart Failure

Keywords

heart failurepitavastatinpravastatinstatin

Outcome Measures

Primary Outcomes (1)

  • Rate and number of hospitalization for cardiovascular cause; Lipid profile

    52week

Secondary Outcomes (4)

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

    52 week

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

    52 week

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

    52 week

  • Cardiovascular mortality

    52 week

Study Arms (2)

1

ACTIVE COMPARATOR

strong statin

Drug: pitavastatin

2

ACTIVE COMPARATOR

mild statin

Drug: pravastatin

Interventions

pitavastatinDRUG

pitavastatin 4mg once daily

1
pravastatinDRUG

pravastatin 10mg once daily

2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SEOUL St. Mary's Hospital

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

Location

Related Publications (1)

  • 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.

    PMID: 25378974DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

pitavastatinPravastatin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Sang Hong Baek, MD, PhD

    KangNam St. Mary's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2014

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

KR(1)