Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000766910
Ethics application status
Approved
Date submitted
30/11/2010
Date registered
21/07/2011
Date last updated
21/07/2011
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
None
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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
Death
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
Re-hospitalization
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
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
Country [1] 258157 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Commercial Rd
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 257329 0
None
Name [1] 257329 0
Address [1] 257329 0
Country [1] 257329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260137 0
Alfred Health Research and Ethics Committee
Ethics committee address [1] 260137 0
Ethics committee country [1] 260137 0
Australia
Date submitted for ethics approval [1] 260137 0
Approval date [1] 260137 0
26/11/2010
Ethics approval number [1] 260137 0
1/10/0344

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 15217 0
+61 3 9076 3263
Fax 15217 0
Email 15217 0
[email protected]
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
Australia
Phone 6145 0
+61 3 9076 3263
Fax 6145 0
Email 6145 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.