Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Drug: Rosuvastatin; Other: guideline directed therapy; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03255044

48

Details and patient eligibility

About

There is a controversy whether statins are beneficial in patients with heart failure or not. Trials in which lipophilic statins have been used revealed positive results, unlike major studies where hydrophilic statins were administered. This trial is designed to compare the effects of lipophilic versus hydrophilic statin use in patients with heart failure.

Enrollment: 85 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• older than 18 years (of both sexes)
• diagnosed with stable chronic heart failure NYHA class II-III
• ejection fraction < 40 % as assessed by 2D echocardiography
• who have been optimized on Guideline Directed treatment for heart failure for at least a month prior to enrolling.

Exclusion criteria

• Known hypersensitivity to statin
• Treatment with statins during the past month prior to study.
• Serum creatinine > 3 mg/dl
• Significant liver disease: liver enzymes 2.5 folds the upper normal limit
• Malignancy
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups

Lipophilic statin

Active Comparator group

Description:

Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.

Treatment:

Other: guideline directed therapy

Drug: Atorvastatin

Hydrophilic statin

Active Comparator group

Description:

Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.

Treatment:

Other: guideline directed therapy

Drug: Rosuvastatin