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

Yonsei University

Status: Completed

Conditions: Acute Heart Failure

Treatments: Drug: statin

Study type: Interventional

Funder types: Other

Identifiers

NCT01127945

4-2010-0014

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

atorvastatin 80mg

Experimental group

Treatment:

Drug: statin

conventional therapy (for heart failure)

Active Comparator group

Treatment:

Drug: statin