N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00532688
• Other study ID #: 132/07
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 19, 2007
• Last updated: September 19, 2007
• Start date: September 2007
• Est. completion date: February 2008

Study information

• Verified date: September 2007
• Source: Bayside Health
• Contact: David Kaye, PhD FRACP
• Phone: 610390762000
• Email: david.kaye[@]baker.edu.au
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration (TGA)Australia: National Health and Medical Research Council (NHMRC)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2008
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• N-acetylcysteine
28 days of oral n-acetylcysteine (500mg bd)(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 with tests repeated again at 4 weeks and 9 weeks.

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

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