Heart Failure
Conditions
Keywords
statin, hydrophilic, lipophilic
Brief summary
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.
Interventions
DRUGAtorvastatin
Atorvastatin administered as well as standard heart failure therapy
DRUGRosuvastatin
Rosuvastatin administered as well as standard heart failure therapy
OTHERguideline directed therapy
standard heart failure therapy
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiac markers | 6 months | NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2) |
| Left Ventricular Ejection Fraction (LVEF) | 6 months | — |
| Left Ventricular End-diastolic volume (LVEDV) | 6 months | — |
| Left Ventricular End-systolic volume (LVESV) | 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Living with Heart Failure Questionnaire( MLHFQ) | 6 months | — |
| Packer composite outcome | 6 months | * 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse cardiac events | 6 months | * Cardiovascular death * All cause death * Non- fatal myocardial infarction * Stroke |
| Incidence of Hospitalization | 6 months | Defined as hospitalization for worsening of heart failure for more than 24 hours and demanding aggressive intervention (IV inotropics, diuretics etc..) |
Countries
Egypt
Outcome results
None listed