Heart failure with systolic dysfunction Circulatory System Heart failure
Conditions
Interventions
Simvastatin 40 mg orally (or placebo) once a day (in the evening) will be administered for 6 weeks to each study participant.
Sponsors
Belfast Health and Social Care Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, over 18 years of age 2. Diagnosis of heart failure with an ejection fraction less than 35% determined by 2D echocardiography. Patients will be typically receiving maximal therapy for treatment of heart failure, including loop diuretics, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers and spironolactone. 3. Patients must also be able to give informed consent, and to attend for follow up appointments
Exclusion criteria
Exclusion criteria: 1. History of diabetes mellitus (fasting glucose greater than 7 mmol/L) or uncontrolled hypertension (blood pressure [BP] greater than 140/90 mmHg) or are receiving the thienopyridine derivative clopidogrel 2. Abnormal liver function (defined as aspartate aminotransferase [AST] or alanine aminotransferase [ALT] greater than three times upper limit of normal) or have had a previous documented adverse reaction to statin therapy or hypersensitivity to simvastatin or any of the excipients 3. Pregnant or lactating 4. Any patient who has an adverse reaction to statin therapy following initiation of treatment 5. Patients taking potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, human immunodeficiency virus [HIV] protease inhibitors, erythromycin, clarithromycin) 6. Patients taking cyclosporin, gemfibrozil or greater than 1 g/day niacin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in levels of superoxide, peroxynitrite, nitric oxide, tetrahydrobiopterin and brachial artery flow mediated dilatation and pulse contour analysis. Each outcome measure will be assessed at an initial visit, and then following randomisation and 6 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in levels of markers of left ventricular (LV) dysfunction, adrenomedullin, N-terminal prohormone brain natriuretic peptide (NT proBNP) and intermedin. Each outcome measure will be assessed at an initial visit, and then following randomisation and 6 weeks of treatment. | — |
Countries
United Kingdom
Outcome results
None listed