Kidney Failure, Chronic Clinical Trial
Official title:
Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.
Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure leads to improvements in vascular function and in renal function.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | February 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age 18 to 75 years inclusive; - Patients with chronic heart failure NYHA II, III and IV and LVEF<40%. Stable medications for 1 month. Not admitted to hospital in the past month. - Chronic renal failure with GFR (as estimated by the Cockroft Gault equation) of >30 ml/min and <50 ml/min not on any form of dialysis. Exclusion Criteria: - Age <18 and >75 years; - Myocardial infarction in the preceding six months; - Acute decompensation of renal function or heart failure in the last 30 days; - Allergy to n-acetylcysteine or glyceryl trinitrate; - Contraindications to the use of glyceryl trinitrate as per the product information lodged with the PBS (Australia); - On treatment with allopurinol, vitamin C or vitamin E or other antioxidant therapy at time of randomisation (statins are acceptable); - Acute decompensation of another organ system in the last 30 days; - Current pregnancy. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Alfred Hospital | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Bayside Health | The Alfred |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vascular function via non invasive ultrasound measured flow mediated dilatation | baseline, 4 weeks and 9 weeks | ||
Primary | Estimated glomerular filtration rate calculated with Cockroft Gault equation. | baseline, 4 weeks, 9 weeks | ||
Secondary | Symptoms of heart failure | baseline, 4 weeks, 9 weeks | ||
Secondary | Death | baseline, 4 weeks, 9 weeks | ||
Secondary | Serum BNP (brain natriuretic peptide) | baseline, 4 weeks, 9 weeks |
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