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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 registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical effects of N-acetylcysteine in the treatment of acute decompensated heart failure
Scientific title
Randomised blinded control pilot trial investigating the effect of N-acetylcysteine in the treatment of acute decompensated heart failure
Secondary ID [1] 262672 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute decompensated heart failure 258740 0
Condition category
Condition code
Cardiovascular 258891 258891 0 0
Other cardiovascular diseases

Study type
Description of intervention(s) / exposure
Oral N-acetylcysteine - 600mg twice daily for 5 days initiated within 24 hours of admission for acute decompensated heart failure
Intervention code [1] 257685 0
Treatment: Drugs
Comparator / control treatment
Placebo-composed of the vehicle solution alone twice daily for 5 days initiated within 24 hours of admission for acute decompensated heart failure.
Control group

Primary outcome [1] 259749 0
The primary outcome will be the between group distribution of treatment success, treatment failure or no change in the patient?s clinical condition at Day 5. Treatment success = improvement in symptoms at D5. Treatment failure = death, readmission, worsening symptoms or signs of HF at D5, worsening renal function (= >27umol/L rise in creatinine).
Timepoint [1] 259749 0
Day 5 after hospital admission
Primary outcome [2] 269261 0
The co-primary end-point is an improvement in forearm blood flow (measured by venous occlusion plethysmography and endoPAT).
Timepoint [2] 269261 0
Day 5 after hospital admission
Secondary outcome [1] 268504 0
Timepoint [1] 268504 0
Day 30
Secondary outcome [2] 268505 0
Worsening renal function (= >27umol/L rise in creatinine)
Timepoint [2] 268505 0
Day 30
Secondary outcome [3] 268506 0
Timepoint [3] 268506 0
Day 30
Secondary outcome [4] 268507 0
Worsening HF (KCCQ heart failure questionaire & blinded clinical assessment by the treating physician)
Timepoint [4] 268507 0
Day 30

Key inclusion criteria
-Hospital admission with acute decompensated HF including congestion (or) hypotension (or) worsening renal function (or) other end organ dysfunction.
-NYHA Class III or IV
-LVEF < 40%
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Age < 18, and >75
-LVAD or ECMO in situ or likely requirement for LVAD/ECMO within 24 hrs
-endotracheal intubation/ventilation
-cardiac or other solid organ transplantation
-STEMI at presentation
-Allergy to n-acetylcysteine
- pregnancy

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients admitted to the Heart Failure service at the Alfred Hospital are screened for eligibility. Allocation is by sealed opaque envelopes generated randomly by clinical trials section in Alfred Hospital pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation by pharmacy
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258157 0
Government body
Name [1] 258157 0
Supported as a part of NHMRC Program Grant
Address [1] 258157 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 258157 0
Primary sponsor type
Alfred Health
Commercial Rd
Prahran VIC 3181
Secondary sponsor category [1] 257329 0
Name [1] 257329 0
Address [1] 257329 0
Country [1] 257329 0

Ethics approval
Ethics application status
Ethics committee name [1] 260137 0
Alfred Health Research and Ethics Committee
Ethics committee address [1] 260137 0
Commercial Rd
VIC 3181
Ethics committee country [1] 260137 0
Date submitted for ethics approval [1] 260137 0
Approval date [1] 260137 0
Ethics approval number [1] 260137 0

Brief summary
Heart failure is a condition cause by heart muscle weakness. As a result the circulation to the body becomes inefficient and blood flow tends to fall. We are studying whether a simple medicine which is used in other settings can improve blood flow and thus outcomes for patients admitted to hospital with heart failure.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31970 0
Address 31970 0
Country 31970 0
Phone 31970 0
Fax 31970 0
Email 31970 0
Contact person for public queries
Name 15217 0
Prof David Kaye
Address 15217 0
Heart Centre
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 15217 0
Phone 15217 0
+61 3 9076 3263
Fax 15217 0
Email 15217 0
Contact person for scientific queries
Name 6145 0
Prof David Kaye
Address 6145 0
Heart Centre
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 6145 0
Phone 6145 0
+61 3 9076 3263
Fax 6145 0
Email 6145 0

No information has been provided regarding IPD availability
Summary results
No Results