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CompletedNCT01127945Updated Feb 5, 2014

Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients

An interventional study of statin in Acute Heart Failure, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-05.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

This is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute heart failure patients.

02

Conditions studied

  • Acute Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 50 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Dyspnea at rest or minimal activity
  • Tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray

Exclusion criteria

Exclusion Criteria:

  • Acute coronary Syndrome
  • Hospitalization plan for PTCA or CABG
  • Cardiogenic shock (Systolic Blood Pressure \< 80mmHg)
  • Uncontrolled hypertension (Systolic Blood Pressure > 180mmHg)
  • Allergy, adverse drug reaction, hypersensitivity to statin
  • Troponin > 5 times upper limit of normal (ULN)
  • Creatinine kinase-MB level > 3 times ULN
  • AST, ALT > 3 times ULN or acute hepatitis
  • Current or past history of muscle disease, rhabdomyolysis
  • Life expectancy \< 6 months (e.g. metastatic malignancy, liver cirrhosis)
  • Pregnancy or women at age of childbearing potential
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    atorvastatin 80mg

    Drug: statin

  • Active comparator
    conventional therapy (for heart failure)

    Drug: statin

Interventions

  • Drugstatin

    1. adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy 2. acute heart failure therapy

06

What researchers measure

Primary outcomes

  1. hsCRP levels

    to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure

    Time frame: at hospital day #4

07

Study locations

1 site
  • Severance Cardiovascular hospital, Yonsei University College of Medicine
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01127945
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
May 21, 2010
Start date
May 2010
Primary completion
Jul 2013
Completion
Nov 2013
Last update
Feb 5, 2014

Study contacts

Seok-Min Kang
study director · Severance Cardiovascular hospital, Yonsei University College of Medicine
Hui-Nam Pak
principal investigator · Severance Cardiovascular hospital, Yonsei University College of Medicine
Boyoung Joung
principal investigator · Severance Cardiovascular hospital, Yonsei University College of Medicine
Sungha Park
principal investigator · Severance Cardiovascular hospital, Yonsei University College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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