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Completed

NCT Number: NCT01127945

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

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.

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Key information

Conditions

Acute Heart Failure

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Cardiovascular hospital, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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)
  • Pregnancy or women at age of childbearing potential

Treatment and study plan

Statin

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 21, 2010
Registry last updated
Feb 5, 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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