Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Rosuvastatin
* Other: guideline directed therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipophilic statin<br>Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure. | Drug: Atorvastatin<br>* Atorvastatin administered as well as standard heart failure therapy<br>* Other names: standard heart failure therapy;Other: guideline directed therapy<br>* standard heart failure therapy<br>|
| Active Comparator: Hydrophilic statin<br>Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure. | Drug: Rosuvastatin<br>* Rosuvastatin administered as well as standard heart failure therapy<br>* Other names: standard heart failure therapy;Other: guideline directed therapy<br>* standard heart failure therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction (LVEF) |  | 6 months | 
| Left Ventricular End-diastolic volume (LVEDV) |  | 6 months | 
| Left Ventricular End-systolic volume (LVESV) |  | 6 months | 
| cardiac markers | NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota Living with Heart Failure Questionnaire( MLHFQ) |  | 6 months | 
| Packer composite outcome | Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment: markedly/moderately improved (or both) but did not experience any major adverse clinical events during the course of the trial (death or hospitalization). Patients are considered worse if they experienced a major clinical event during the duration of treatment or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statin, hydrophilic, lipophilic