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Effect of statins on functional regulation of endothelial nitric oxide synthase (eNOS) in heart failure

Not Applicable
Completed
Conditions
Heart failure with systolic dysfunction
Circulatory System
Heart failure
Registration Number
ISRCTN41260134
Lead Sponsor
Belfast Health and Social Care Trust (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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