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Trial registered on ANZCTR


Registration number
ACTRN12607000330448
Ethics application status
Approved
Date submitted
19/02/2007
Date registered
19/06/2007
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Date results information initially provided
29/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The safety and efficacy of recombinant neuregulin-1 (rhNRG-1) in patients with stable chronic heart failure
Scientific title
The safety and efficacy of recombinant neuregulin-1 (rhNRG-1) in patients with stable chronic heart failure
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 1879 0
Condition category
Condition code
Cardiovascular 1973 1973 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous administration of recombinant Human neuregulin-1 (novel drug). 1.2 mcg/kg/day for 1 day then 2.4 mcg/kg/day intravenously for 10 days.
Intervention code [1] 1611 0
Treatment: Drugs
Comparator / control treatment
No control arm.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2790 0
Primary Safety Outcome:
To assess the safety of rhNRG-1 in patients with stable symptomatic chronic heart failure, as determined by the incidence and severity of adverse clinical events, new electrocardiographic and laboratory abnormalities
Timepoint [1] 2790 0
For 3 months after intervention commencement
Primary outcome [2] 2791 0
Primary Efficacy Outcome:
To assess the effect of rhNRG-1 on left ventricular function and remodeling as determined by change in Left ventricular ejection fraction(LVEF), Left ventricular end diastolic volume (LVEDV) and left ventricular end systolic volume (LVESV), measured by MRI
Timepoint [2] 2791 0
Measured at 12 days and 3 months post-baseline
Secondary outcome [1] 4710 0
1.To assess the effect of rhNRG-1 on acute haemodynamics (cardiac output, left and right heart filling pressures, pulmonary and systemic blood pressures, and systemic and pulmonary vascular resistance after single and repeated dosing.
Timepoint [1] 4710 0
With repeated measurements over the first 24 hours and also at day 12 and 3 months
Secondary outcome [2] 4711 0
2.To assess the effect of rh-NRG-1 on the following neuro-hormonal and immunological markers in blood: noradrenaline, aldosterone, endothelin-1, nt-proBNP, terminal propeptide of type III procollagen (PIIINP), highly sensitive c-reactive protein (hsCRP),Tumour necosis factor alpha (TNF alpha) and interleukin 6 (IL-6).
Timepoint [2] 4711 0
Secondary outcome [3] 4712 0
3. To assess the effect of rh-NRG-1 on interstitial myocardial fibrosis as measured by magnetic resonance imaging
Timepoint [3] 4712 0
At day 12 and 3 months

Eligibility
Key inclusion criteria
Written informed consent. Left ventricular systolic dysfunction (LVEF < 40%) secondary to ischaemic heart disease or cardiomyopathyStable NYHA Class II or III symptomatic heart failurePatients established on ACEI/ARA and beta blocker with stable doses of these medications for the preceding 3 months
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NYHA Class I or IV heart failureAcute myocardial infarction or unstable angina within 3 monthsCoronary artery revascularization or left ventricular remodeling surgery within preceding 3 monthsPatients awaiting coronary artery revascularisation or left ventricular remodeling surgeryImplanted pacemaker or defibrillatorChronic atrial fibrillation or flutterPrimary valvular heart diseaseHypertrophic or restrictive cardiomyopathyClaustrophobiaPregnancy or lactation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2113 0
Commercial sector/Industry
Name [1] 2113 0
Zensun (Aust) Sci & Tech Co., Ltd.
Address [1] 2113 0
Country [1] 2113 0
Australia
Primary sponsor type
Individual
Name
Peter Macdonald
Address
Country
Secondary sponsor category [1] 1922 0
Individual
Name [1] 1922 0
Andrew Jabbour
Address [1] 1922 0
Country [1] 1922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3905 0
St Vincent's Hospital
Ethics committee address [1] 3905 0
Sydney NSW 2010
Ethics committee country [1] 3905 0
Australia
Date submitted for ethics approval [1] 3905 0
Approval date [1] 3905 0
24/08/2006
Ethics approval number [1] 3905 0
H06/035

Summary
Brief summary
This will test the safety and efficacy of a new drug called recombinant human Neuregulin-1 in patients with chronic stable heart failure. We hope to establish that recombinant human Neuregulin-1 (rhNRG-1) can be administered safely and that its administration results in improved heart structure and function as measured by cardiac MRI at 12 days and 3 months.
Trial website
Trial related presentations / publications
https://onlinelibrary.wiley.com/doi/full/10.1093/eurjhf/hfq152
Public notes

Contacts
Principal investigator
Name 27545 0
Address 27545 0
Country 27545 0
Phone 27545 0
Fax 27545 0
Email 27545 0
Contact person for public queries
Name 10800 0
Andrew Jabbour
Address 10800 0
Cardiology Department
Level 4 Xavier Buidling
St Vincent's Hospital
Darlinghurst NSW 2010
Country 10800 0
Australia
Phone 10800 0
02 83821111
Fax 10800 0
Email 10800 0
ajabbour@stvincents.com.au
Contact person for scientific queries
Name 1728 0
Andrew Jabbour
Address 1728 0
Cardiology Department
Level 4 Xavier Buidling
St Vincent's Hospital
Darlinghurst NSW 2010
Country 1728 0
Australia
Phone 1728 0
02 83821111
Fax 1728 0
Email 1728 0
ajabbour@stvincents.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary