Effect of HMG-Co A reductase inhibition on endothelial dysfunction, bioavailability of tetrahydrobiopterin (BH4) and functional regulation of endothelial nitric oxide synthase (eNOS) in human heart failure. - Effect of statins on functional regulation of eNOS in heart failure.

Belfast Health and Social Care Trust0 个研究点目标入组 60 人开始时间: 2008年10月22日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•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

•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.

发起方