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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01127945
Enrollment
50
Registered
2010-05-21
Start date
2010-05-31
Completion date
2013-11-30
Last updated
2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure

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.

Interventions

DRUGstatin

1. adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy 2. acute heart failure therapy

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
hsCRP levelsat hospital day #4to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026