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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01127945
First received: May 18, 2010
Last updated: February 4, 2014
Last verified: February 2014
  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:


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


Enrollment: 50
Study Start Date: May 2010
Study Completion Date: November 2013
Primary Completion Date: July 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127945

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01127945     History of Changes
Other Study ID Numbers: 4-2010-0014
Study First Received: May 18, 2010
Last Updated: February 4, 2014
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 July 26, 2014