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

Acute Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127945
• Other study ID #: 4-2010-0014
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: February 4, 2014
• Start date: May 2010
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• statin
adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy acute heart failure therapy

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes