Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00532688




Registration number
NCT00532688
Ethics application status
Date submitted
19/09/2007
Date registered
20/09/2007
Date last updated
20/09/2007

Titles & IDs
Public title
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
Scientific title
Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.
Secondary ID [1] 0 0
132/07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive 0 0
Kidney Failure, Chronic 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - N-acetylcysteine

Experimental: 1 - 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.

Placebo Comparator: 2 - 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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Vascular function via non invasive ultrasound measured flow mediated dilatation
Timepoint [1] 0 0
baseline, 4 weeks and 9 weeks
Primary outcome [2] 0 0
Estimated glomerular filtration rate calculated with Cockroft Gault equation.
Timepoint [2] 0 0
baseline, 4 weeks, 9 weeks
Secondary outcome [1] 0 0
Symptoms of heart failure
Timepoint [1] 0 0
baseline, 4 weeks, 9 weeks
Secondary outcome [2] 0 0
Death
Timepoint [2] 0 0
baseline, 4 weeks, 9 weeks
Secondary outcome [3] 0 0
Serum BNP (brain natriuretic peptide)
Timepoint [3] 0 0
baseline, 4 weeks, 9 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2008
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00532688
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Kaye, PhD FRACP
Address 0 0
Alfred Heart Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Kaye, PhD FRACP
Address 0 0
Country 0 0
Phone 0 0
610390762000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00532688