N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

• Status: Unknown status
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure leads to improvements in vascular function and in renal function.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Collaborator: The Alfred
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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.