N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

Phase 2

• Conditions: Heart Failure, Congestive; Kidney Failure, Chronic
• Interventions: Drug: N-acetylcysteine

• Registration Number: NCT00532688
• Lead Sponsor: Bayside Health

Brief Summary

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

Detailed Description

Ten patients will be invited to participate in the trial. After obtaining informed consent, the ten patients will be randomly assigned to one month of treatment with oral n-acetylcysteine 500mg or placebo twice daily for thirty days in addition to their regular therapy. At enrolment the patients will be educated and counselled about the trial and the intervention medication. Patients will also have a blood test (serum creatinine) that will allow the calculation of their renal function by use of the Cockroft Gault equation. Blood samples will also be frozen and stored. Patients will also undergo an ultrasound test of the function of their arm blood vessels. Both the blood test and the ultrasound test will be repeated at the completion of the thirty day trial period. Again the blood test sample will be frozen and stored. Subjects will then cross over to the other treatment arm for a further one month period, with the same testing at the end.

Study Timeline

• Status Verified: 2007-09
• Study Start: 2007-09
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Last Update Submitted: 2007-09-19
• Study First Posted: 2007-09-20
• Last Update Posted: 2007-09-20
• Study Completion: 2008-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	N-acetylcysteine	28 days of oral distilled water (5ml) (in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to intervention (N-acetylcysteine 500mg oral bd) for 28 days after one week washout period with tests repeated again at 4 weeks and 9 weeks.
1	N-acetylcysteine	5 patients: 28 days of n-acetylcysteine (in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to placebo for 28 days after one week washout period.

Primary Outcome Measures

Name	Time	Method
Vascular function via non invasive ultrasound measured flow mediated dilatation	baseline, 4 weeks and 9 weeks
Estimated glomerular filtration rate calculated with Cockroft Gault equation.	baseline, 4 weeks, 9 weeks

Secondary Outcome Measures

Name	Time	Method
Symptoms of heart failure	baseline, 4 weeks, 9 weeks
Death	baseline, 4 weeks, 9 weeks
Serum BNP (brain natriuretic peptide)	baseline, 4 weeks, 9 weeks

Trial Locations

Locations (1)

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia