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Clinical Trials/NCT01127945
NCT01127945
Completed
N/A

A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients

Yonsei University1 site in 1 country50 target enrollmentMay 2010
Interventionsstatin

Overview

Phase
N/A
Intervention
statin
Conditions
Acute Heart Failure
Sponsor
Yonsei University
Enrollment
50
Locations
1
Primary Endpoint
hsCRP levels
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
November 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

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)

Arms & Interventions

atorvastatin 80mg

Intervention: statin

conventional therapy (for heart failure)

Intervention: statin

Outcomes

Primary Outcomes

hsCRP levels

Time Frame: at hospital day #4

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

Study Sites (1)

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