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

February 4, 2014 updated by: Yonsei University

A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Severance Cardiovascular Hospital, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at hospital day #4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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