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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipophilic statin | Active Comparator | Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure. |
|
| Hydrophilic statin | Active Comparator | Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin administered as well as standard heart failure therapy |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Living with Heart Failure Questionnaire( MLHFQ) | 6 months | |
| Packer composite outcome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse cardiac events |
| 6 months |
| Incidence of Hospitalization | Defined as hospitalization for worsening of heart failure for more than 24 hours and demanding aggressive intervention (IV inotropics, diuretics etc..) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospital Cardiology Rehab Unit | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33294980 | Derived | El Said NO, El Wakeel LM, Khorshid H, Darweesh EAG, Ahmed MA. Impact of lipophilic vs hydrophilic statins on the clinical outcome and biomarkers of remodelling in heart failure patients: A prospective comparative randomized study. Br J Clin Pharmacol. 2021 Jul;87(7):2855-2866. doi: 10.1111/bcp.14695. Epub 2021 Jan 3. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Rosuvastatin | Drug | Rosuvastatin administered as well as standard heart failure therapy |
|
|
| guideline directed therapy | Other | standard heart failure therapy |
|
| 6 months |
| 6 months |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |