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

This study is currently recruiting participants.
Verified August 2011 by Yonsei University
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01127945
First received: May 18, 2010
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Acute Heart Failure
 Drug: statin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • hsCRP levels [ Time Frame: at hospital day #4 ] [ Designated as safety issue: Yes ]
    to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: atorvastatin 80mg Drug: statin
  1. adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy
  2. acute heart failure therapy
Active Comparator: conventional therapy (for heart failure) Drug: statin
  1. adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy
  2. acute heart failure therapy

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  • Pregnancy or women at age of childbearing potential
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127945

Contacts
Contact: Seok-Min Kang 82-2-2228-845 smkang@yuhs.ac

Locations
Korea, Republic of
Severance Cardiovascular hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Seok - Min Kang            
Sponsors and Collaborators
Yonsei University
Investigators
Study Director: Seok-Min Kang Severance Cardiovascular hospital, Yonsei University College of Medicine
Principal Investigator: Hui-Nam Pak Severance Cardiovascular hospital, Yonsei University College of Medicine
Principal Investigator: Boyoung Joung Severance Cardiovascular hospital, Yonsei University College of Medicine
Principal Investigator: Sungha Park Severance Cardiovascular hospital, Yonsei University College of Medicine
  More Information

No publications provided

Responsible Party: Seok-Min Kang/Associate professor, Severance Cardiovascular hospital, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT01127945     History of Changes
Other Study ID Numbers: 4-2010-0014
Study First Received: May 18, 2010
Last Updated: August 18, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 17, 2012