Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001336370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/10/2026
Date registered
Help: Date registered
5/11/2026
Date last updated
Help: Date last updated
5/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
5/11/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The FH-RECALL Study: Genetic confirmation, family member screening and contemporary cholesterol management for younger patients that required coronary bypass surgery with likely familial hypercholesterolaemia.
Scientific title
Engaging younger coronary bypass patients with familial hypercholesterolaemia: genetic confirmation, cascade testing and contemporary lipid management
Additional trial identifiers [1] 318608 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FH-RECALL (Familial hypercholesterolaemia – Recall, Evaluation, Cascade testing And Lipid-Lowering)
Related trial records

Health condition
Health condition(s) studied:
Familial Hypercholesterolaemia 343809 0
Coronary artery bypass grafting 343929 0
Coronary artery disease 343930 0
Atherosclerosis 343932 0
Condition category
Condition code
Human Genetics and Inherited Disorders 339947 339947 0 0
Other human genetics and inherited disorders
Metabolic and Endocrine 339948 339948 0 0
Other metabolic disorders
Cardiovascular 339949 339949 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Patients with previously identified likelihood of familial hypercholesterolaemia (Dutch lipid clinical network score greater than or equal to six) are recalled to a clinic run by a cardiology nurse practitioner with cardiologist oversight (Principal investigator). They are offered genetic testing for themselves and their family members if a mutation is identified as well as optimisation of there lipid lowering therapy by reassessing their eligibility for PBS treatment options (statins, ezetimibe, PCSK9 inhibitors, icosapent ethyl)

Index patients will be offered two clinic appointments approximately 6 months apart, family members will be offered to choice of a clinic appointment or general practitioner follow-up with cardiologist oversight.

the appointments are estimated to take approximately 30-45 minutes. The initial clinic will assess for any further vascular events that occurred since participants index coronary artery bypass grafting, LDL target attainment and current lipid lowering treatments and a thorough family history and pedigree completion. Patients will also be assessed for PBS eligibility of novel therapies and commencement if eligible.

The second clinic will be used to reassess lipid levels after optimising treatment and for communication of genetic screening results (approximate time to result from collection of 3 months). Patients will also complete a questionnaire about their experience of the familial hypercholesterolaemia clinic.

The clinics can occur as a telehealth visit or a face to face visit.
Intervention code [1] 335513 0
Diagnosis / Prognosis
Intervention code [2] 335514 0
Early detection / Screening
Intervention code [3] 335515 0
Treatment: Drugs
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 347120 0
Uptake of index genetic testing: the proportion of contactable patients who consent to and complete testing.
Timepoint [1] 347120 0
upon completion of pathology reporting of all participants.
Primary outcome [2] 347123 0
The proportion of tested patients with genetically confirmed familial hypercholesterolaemia.
Timepoint [2] 347123 0
Upon completion of pathology reporting of all participants.
Primary outcome [3] 347214 0
The number of first degree relatives that are cascade tested.
Timepoint [3] 347214 0
Assessed at the conclusion of the study.
Secondary outcome [1] 469009 0
Baseline Low-density lipoprotein cholesterol (LDL-C) levels among participants.
Timepoint [1] 469009 0
Upon completion of all baseline testing.
Secondary outcome [2] 469010 0
LDL-C levels approximately six months after initial clinic review.
Timepoint [2] 469010 0
Upon completion of repeat 6-month measurement of all index participants.
Secondary outcome [3] 469012 0
Lipoprotein(a) levels among index patients.
Timepoint [3] 469012 0
Upon completion of testing of all index patients.
Secondary outcome [4] 469013 0
Interval major adverse cardiovascular events (MACE) since index coronary artery bypass grafting (CABG).
Timepoint [4] 469013 0
Upon completion of initial clinic review of all index participants.
Secondary outcome [5] 469642 0
The number of second degree relatives that are cascade tested.
Timepoint [5] 469642 0
Assessed at the conclusion of the study.
Secondary outcome [6] 469643 0
The total number of patients newly genetically diagnosed patients with familial hypercholesterolaemia
Timepoint [6] 469643 0
Assessed at the conclusion of the study.
Secondary outcome [7] 469644 0
The number of newly genetically diagnosed patients with familial hypercholesterolaemia per index patient.
Timepoint [7] 469644 0
Assessed at the conclusion of the study.
Secondary outcome [8] 469645 0
The proportion of patients that achieve an LDL-C target of less than 1.4 mmol/L at approximately six months after initial clinic review.
Timepoint [8] 469645 0
Upon completion of repeat 6-month measurement of all index participants.
Secondary outcome [9] 469646 0
The proportion of index patients with pharmaceutical benefits scheme (PBS) eligibility and subsequent commencement on a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor.
Timepoint [9] 469646 0
Assessed at the conclusion of the study.
Secondary outcome [10] 469647 0
The proportion of index patients with PBS eligibility and subsequent commencement on ezetimibe.
Timepoint [10] 469647 0
Assessed at the conclusion of the study.
Secondary outcome [11] 469648 0
The proportion of index patients with PBS eligibility and subsequent commencement on icosapent ethyl.
Timepoint [11] 469648 0
Assessed at the conclusion of the study.
Secondary outcome [12] 469716 0
The number of participants that consent to participate in the study.
Timepoint [12] 469716 0
Assessed at the conclusion of the study.
Secondary outcome [13] 469717 0
The average time to result from request date of genetic testing.
Timepoint [13] 469717 0
Assessed at the conclusion of the study.
Secondary outcome [14] 469718 0
the uptake of blood compared to saliva testing among patients that undergo genetic testing.
Timepoint [14] 469718 0
Assessed at the conclusion of the study.
Secondary outcome [15] 469719 0
The proportion of patients that are required from direct notification.
Timepoint [15] 469719 0
Assessed at the conclusion of the study.
Secondary outcome [16] 469720 0
The number of relatives contacted per index patient.
Timepoint [16] 469720 0
Assessed at the conclusion of the study.
Secondary outcome [17] 469721 0
Decision Regret of the familial hypercholesterolaemia recall and clinic experience. This will be assessed as a composite outcome (average score of 5 questionnaire items).
Timepoint [17] 469721 0
Assessed at the conclusion of the study.
Secondary outcome [18] 469722 0
Acceptability of intervention measure (AIM)
Timepoint [18] 469722 0
Assessed at the conclusion of the study.
Secondary outcome [19] 470284 0
The proportion of patients that have an LDL-C of less than 1.4 mmol/L at initial clinic review.
Timepoint [19] 470284 0
Upon completion of all baseline testing.
Secondary outcome [20] 470344 0
The proportion of patients that have an LDL-C of less than 1.8 mmol/L at initial clinic review.
Timepoint [20] 470344 0
Upon completion of all baseline testing.
Secondary outcome [21] 470345 0
The proportion of patients that achieve an LDL-C target of less than 1.8 mmol/L at approximately six months after initial clinic review.
Timepoint [21] 470345 0
Upon completion of repeat 6-month measurement of all index participants.

Eligibility
Key inclusion criteria
Member of the primary (or, if activated, expansion) cohort. - Primary cohort is patients of age less than 60 years of age at time of coronary artery bypass grafting with Dutch lipid clinical network score greater than or equal to 6.

Alive and contactable

Aged greater than or equal to 18 years and able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Deceased, or permanently relocated without a contactable care provider (relocation will trigger a documented attempt to transfer care/information).
• Known prior FH genetic result. Patients with a previously documented Positive/Likely Positive variant (including the 2 already identified in the parent cohort) do not require index testing and proceed directly to cascade testing and treatment review. Patients with a prior variant of uncertain significance (VUS) only are managed per current guidance.
• Uncharacterised secondary causes of severe hypercholesterolaemia that would invalidate the FH phenotype.

Study design
Purpose of the study
Diagnosis
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2027
Actual
Date of last participant enrolment
Anticipated
1/01/2028
Actual
Date of last data collection
Anticipated
1/01/2029
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 323186 0
Government body
Name [1] 323186 0
Australian Department of Health, Disability and Ageing, Medical Research Future Fund (MRFF)
Country [1] 323186 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Black - Royal Hobart Hospital
Address
Country
Australia
Secondary sponsor category [1] 326154 0
None
Name [1] 326154 0
Address [1] 326154 0
Country [1] 326154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321588 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 321588 0
Ethics committee country [1] 321588 0
Australia
Date submitted for ethics approval [1] 321588 0
11/08/2026
Approval date [1] 321588 0
21/08/2026
Ethics approval number [1] 321588 0
H40843

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

Contacts
Principal investigator
Name 154174 0
Dr J. Andrew Black
Address 154174 0
Royal Hobart Hospital, 48 Liverpool St, Hobart, Tasmania, 7000
Country 154174 0
Australia
Phone 154174 0
+61 4 0753 3654
Fax 154174 0
Email 154174 0
[email protected]
Contact person for public queries
Name 154175 0
J. Andrew Black
Address 154175 0
Royal Hobart Hospital, 48 Liverpool St, Hobart, Tasmania, 7000
Country 154175 0
Australia
Phone 154175 0
+61 3 6166 8620
Fax 154175 0
Email 154175 0
[email protected]
Contact person for scientific queries
Name 154176 0
J. Andrew Black
Address 154176 0
Royal Hobart Hospital, 48 Liverpool St, Hobart, Tasmania, 7000
Country 154176 0
Australia
Phone 154176 0
+61 3 6166 8620
Fax 154176 0
Email 154176 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After completion of first data analysis
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: please contact principal investigator via email on [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.