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Trial registered on ANZCTR


Registration number
ACTRN12613000525785
Ethics application status
Approved
Date submitted
8/05/2013
Date registered
13/05/2013
Date last updated
1/08/2019
Date data sharing statement initially provided
1/08/2019
Date results information initially provided
1/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of statins on circulating concentrations of the hormone C-type natriuretic peptide
Scientific title
A study to assess NTproCNP as a new potential biomarker of atheroma risk and/or severity through clinical studies of blood samples from donors starting statin drug therapy including healthy donors and those with overt coronary artery disease.
Secondary ID [1] 282466 0
Nil
Universal Trial Number (UTN)
Trial acronym
SONiC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 289085 0
Condition category
Condition code
Cardiovascular 289424 289424 0 0
Coronary heart disease
Cardiovascular 289425 289425 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three subject groups will be recruited. Group 1; twenty healthy fit young adult males aged 20 – 25 years, free of cardiovascular risk factors and with no family history of cardiovascular disease. Group 2; twenty healthy fit older adult males aged 40-60 years with no history (or family history) of cardiovascular disease. Group 3; Twenty male patients recently diagnosed with overt coronary artery disease aged 40-60 year about to start statin drug therapy. None of the subjects in each of the three groups shall have received prior statin therapy. All subjects will receive statin therapy for one week but group 3 subjects will continue thereafter for a period of at least 6 months. An overnight fasted blood sample will be obtained at 0800hrs from all subjects immediately prior to receiving Atovastatin 40mg daily (oral tablet). Additional overnight fasted blood samples will be drawn from all subjects at 0800hrs on days 1, 2 and 7 following initiation of statin therapy. Adherence to drug schedule will be assessed by drug tablet return. Further monthly blood samples will be obtained from group 3 subjects for 6 months. Blood samples will be analysed for lipids (triglycerides, total cholesterol, LDL and HDL), creatinine, high sensitivity C reactive protein (hsCRP), CNP and NTproCNP content. Subjects in groups 1 and 2 with baseline triglyceride > 1.7 mmol/L will be excluded.
Intervention code [1] 287112 0
Early detection / Screening
Intervention code [2] 287137 0
Treatment: Drugs
Comparator / control treatment
Healthy Donors
Control group
Active

Outcomes
Primary outcome [1] 289530 0
Analyse the relative changes in plasma concentrations of NTproCNP following statin treatment in the three groups. Group 1; twenty healthy fit young adult males aged 20 – 25 years. Group 2; twenty healthy fit older adult males aged 40-60 years with no history (or family history) of cardiovascular disease. Group 3; Twenty male patients recently diagnosed with overt coronary artery disease aged 40-60 year about to start statin drug therapy.
Timepoint [1] 289530 0
Baseline, Days 1, 2 and 7 of statin treatment (Groups 1,2 and 3). Months 1-6 of statin treatment for Group 3.
Secondary outcome [1] 302694 0
Determine the relationship of plasma NTproCNP concentrations to plasma lipid markers and high sensitivity C reactive protein.
Timepoint [1] 302694 0
Baseline, Days 1, 2 and 7 of statin treatment (Groups 1,2 and 3). Months 1-6 of statin treatment for Group 3.

Eligibility
Key inclusion criteria
Group 1; Males aged 20-25y. No family history (1st and 2nd degree relatives) of coronary artery disease (CAD), stroke or peripheral vascular disease (PVD). No personal history of high BP, smoking, diabetes, lipid disorders or renal disease. BMI between 18-25. Normal BP (<140 systolic, <90 diastolic). Normal Blood lipid profile.
Group 2; Males aged 40-60y. No family history (1st and 2nd degree relatives) of CAD, stroke or PVD. No personal history of high BP, smoking, diabetes, lipid disorders or renal disease. BMI between 18-25. Normal BP (<140 systolic, <90 diastolic). Normal Blood lipid profile.
Group 3; Males diagnosed with overt coronary artery disease aged 40-60y about to start statin therapy. Allow family history of CAD, stroke or PVD. Allow personal history of high BP, lipid disorder.
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling or unable to give informed consent.
Groups 1 & 2; On medication. BMI > 25. Systolic BP >140, Diastolic BP >90. Triglycerides >1.7mmol/L.
Group 3; Subjects who have previously taken statin medication. Subjects with past episodes of heart failure, diabetics receiving insulin, raised plasma creatinine (> 110umol/L) and metabolic bone disease or recent fracture.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
20/08/2013
Date of last participant enrolment
Anticipated
Actual
25/08/2017
Date of last data collection
Anticipated
Actual
28/02/2018
Sample size
Target
60
Accrual to date
Final
65
Recruitment outside Australia
Country [1] 5070 0
New Zealand
State/province [1] 5070 0

Funding & Sponsors
Funding source category [1] 287248 0
Charities/Societies/Foundations
Name [1] 287248 0
Heart Foundation NZ
Country [1] 287248 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Christchurch Heart Institute
Address
Christchurch Heart Institute,
PO Box 4345,
Christchurch 8140,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 285999 0
None
Name [1] 285999 0
Address [1] 285999 0
Country [1] 285999 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289227 0
The Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 289227 0
Ministry of Health,
No 1 The Terrace,
PO Box 5013,
Wellington 6145,
Ethics committee country [1] 289227 0
New Zealand
Date submitted for ethics approval [1] 289227 0
13/05/2013
Approval date [1] 289227 0
06/06/2013
Ethics approval number [1] 289227 0
13/NTB/67

Summary
Brief summary
The purpose of this study is to test a new potential marker of atheroma risk and/or severity – aminoterminal C-type natriuretic peptide (NTproCNP).
We will follow longitudinally the changes in blood concentrations of NTproCNP in response to the statin, Atovastatin, in healthy male volunteers and male patients who have just been diagnosed with overt coronary artery disease and are about to start statin drug therapy. Three groups of volunteers will be studied, all of whom will not have previously received statin treatment:-
Group 1; 20 normal, healthy male volunteers aged between 20-25 years.
Group 2; 20 normal, healthy male volunteers aged between 40-60 years.
Group 3; 20 male patients aged between 40-60 years recently diagnosed with overt coronary artery disease and about to start statin drug therapy.
All subjects will receive statin therapy for one week but group 3 subjects will continue thereafter for a period of at least 6 months. An overnight fasted blood sample will be obtained from all subjects immediately prior to receiving Atovastatin 40mg daily. Additional overnight fasted blood samples will be drawn from all subjects on days 1, 2 and 7 following initiation of statin therapy. Further monthly blood samples will be obtained from group 3 subjects for 6 months. Blood samples will be analysed for lipids (triglycerides, total cholesterol, LDL and HDL), creatinine, high sensitivity C reactive protein (hsCRP), CNP and NTproCNP content.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39874 0
Dr Timothy Prickett
Address 39874 0
Christchurch Heart Institute,
Department of Medicine,
University of Otago,
PO Box 4345,
Christchurch 8140
Country 39874 0
New Zealand
Phone 39874 0
+643-364-1478
Fax 39874 0
Email 39874 0
tim.prickett@otago.ac.nz
Contact person for public queries
Name 39875 0
Mrs Lorraine Skelton
Address 39875 0
Christchurch Heart Institute,
Department of Medicine,
University of Otago,
PO Box 4345,
Christchurch 8140
Country 39875 0
New Zealand
Phone 39875 0
+643-364-1063
Fax 39875 0
+643-364-0935
Email 39875 0
lorraine.skelton@cdhb.health.nz
Contact person for scientific queries
Name 39876 0
Mrs Lorraine Skelton
Address 39876 0
Christchurch Heart Institute,
Department of Medicine,
University of Otago,
PO Box 4345,
Christchurch 8140
Country 39876 0
New Zealand
Phone 39876 0
+643-364-1063
Fax 39876 0
+643-364-0935
Email 39876 0
lorraine.skelton@cdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Statistical summary data will be published in manuscript for in peer reviewed journals. De-identified data underlying published results will be available to approved investigators on reasonable request.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal.
How or where can data be obtained?
From the principle investigator on reasonable request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3612Study protocol  tim.prickett@otago.ac.nz



Results publications and other study-related documents

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