Heart failure
Conditions
Interventions
Trade Name: Simvastatin Teva
Product Name: Simvastatin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Simvastatin
CAS Numb
Sponsors
Belfast Health and Social Care Trust
Queens University Belfast
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients must be over 18 years of age and have a diagnosis of heart failure based on transthoracic echocardiogram showing left ventricular ejection fraction less than 35 % with New York Heart Association symptom class II - IV. Patients will typically be receiving maximal medical therapy for heart failure. Patients must also be able to give informed consent and be able to attend the department for investigations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they have a history of diabetes mellitus (fasting glucose > 7mmol/l), uncontrolled hypertension (BP > 140/90 mmHg) or are receiving the thienopyridine derivative clopidogrel. Patients will also be excluded if they have abnormal liver function (ALT of AST > 3 times upper limit of normal) or have had a previously documented adverse reaction to statin therapy or hypersensitivity to simvastatin or any of the excipients. Females will be excluded if they are pregnant or lactating. Any patient who has an adverse reaction to statin therapy following initiation of treatment, will be excluded from further participation in the study. Patients taking potent CYP3A4 inhibitors (eg. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin) will be excluded. Patients taking ciclosporin, gemfibrozil, or >1g/day niacin will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the effect of simvastatin on biochemical and functional measures of endothelial function in patients with heart failure.;Secondary Objective: Measures of surrogate markers of cardiac function including NT pro BNP, intermedin and adrenomedullin (all measured in blood samples); Primary end point(s): The primary endpoints will be difference in biochemical and functional measures of endothelial function between placebo and treatment arms of the study. Biochemical markers compared will be: nitric oxide superoxide peroxynitrite tetrahydrobiopterin NT pro BNP adrenomedullin intermedin Functional measures will be: fore arm mediated dilatation and pulse contour analysis | — |
Countries
United Kingdom
Outcome results
None listed