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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01127945
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
42.1
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: atorvastatin 80mg

Drug: statin
adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy acute heart failure therapy
Active Comparator: conventional therapy (for heart failure)

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

Outcome Measures

Primary Outcome Measures

  1. hsCRP levels [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
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:

  • 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

Locations

Site City State Country Postal Code
1 Severance Cardiovascular hospital, Yonsei University College of Medicine Seoul Korea, Republic of

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01127945
Other Study ID Numbers:
  • 4-2010-0014
First Posted:
May 21, 2010
Last Update Posted:
Feb 5, 2014
Last Verified:
Feb 1, 2014
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Feb 5, 2014