Back to resultsStudy to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
Primary Purpose
Acute Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
statin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Heart Failure
Eligibility 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
Sites / Locations
- Severance Cardiovascular hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
atorvastatin 80mg
conventional therapy (for heart failure)
Arm Description
Outcomes
Primary Outcome Measures
hsCRP levels
to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01127945
Brief Title
Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
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 Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
atorvastatin 80mg
Arm Type
Experimental
Arm Title
conventional therapy (for heart failure)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
statin
Intervention Description
adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy
acute heart failure therapy
Primary Outcome Measure Information:
Title
hsCRP levels
Description
to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure
Time Frame
at hospital day #4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok-Min Kang
Organizational Affiliation
Severance Cardiovascular hospital, Yonsei University College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hui-Nam Pak
Organizational Affiliation
Severance Cardiovascular hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Boyoung Joung
Organizational Affiliation
Severance Cardiovascular hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sungha Park
Organizational Affiliation
Severance Cardiovascular hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Cardiovascular hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
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