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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00532688
Other study ID # 132/07
Secondary ID
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
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.

Study Design

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


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
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