Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 18, 2010
CompletedFirst Posted
Study publicly available on registry
May 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFebruary 5, 2014
February 1, 2014
3.2 years
May 18, 2010
February 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
at hospital day #4
Study Arms (2)
atorvastatin 80mg
EXPERIMENTALconventional therapy (for heart failure)
ACTIVE COMPARATORInterventions
1. adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy 2. acute heart failure therapy
Eligibility Criteria
You may qualify if:
- Dyspnea at rest or minimal activity
- Tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest X-ray
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Cardiovascular hospital, Yonsei University College of Medicine
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2010
First Posted
May 21, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2013
Study Completion
November 1, 2013
Last Updated
February 5, 2014
Record last verified: 2014-02