Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000858392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/06/2026
Date registered
Help: Date registered
14/07/2026
Date last updated
Help: Date last updated
3/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
HF-REACH (Heart Failure - Remote Equitable Australian Care through Healthcare Innovation) A Parallel Pragmatic Randomised Controlled Trial of Nurse-Led mHealth Heart Failure Management across Regional Australia to determine its effectiveness on heart failure symptoms/hospitalisation at 6 months
Scientific title
HF-REACH (Heart Failure - Remote Equitable Australian Care through Healthcare Innovation) A Parallel Pragmatic Randomised Controlled Trial of Nurse-Led mHealth Heart Failure Management across Regional Australia to determine its effectiveness on heart failure symptoms/hospitalisation at 6 months
Additional trial identifiers [1] 317685 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Heart Failure 342508 0
Condition category
Condition code
Cardiovascular 338636 338636 0 0
Other cardiovascular diseases
Public Health 338637 338637 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Recent heart failure hospitalisation (90 days): Participants will be stratified at randomisation according to whether they have experienced a heart failure-related hospitalisation within the 90 days preceding enrolment or more than 90 days prior to enrolment.
* Treating clinician training: Treating clinicians (GPs, cardiologists, and participating clinicians) will receive a 30-minute online onboarding session provided by the CardioNexus study team before the first participant is enrolled at their site. The session will cover the study workflow, clinician responsibilities, communication pathways, and management of nurse-generated clinical alerts. Additional support will be available throughout the study as required.
* Mobile application: The Heart Failure mobile application is an existing digital health platform used by CardioNexus for remote heart failure monitoring and has not been developed specifically for this study.
* Heart failure education: Participants allocated to the intervention will receive a 60-minute individual telephone onboarding session with a CardioNexus heart failure nurse covering heart failure, symptom recognition, self-management, use of the mobile application, and when to seek medical care.
* Medication adherence support: Nurses will review medication adherence during scheduled or clinically indicated telephone consultations and reinforce adherence to medications prescribed by the participant’s treating clinician.
* Remote monitoring: Participants will record daily weight, blood pressure, heart rate, and heart failure symptoms using the mobile application for 6 months. Data are reviewed remotely by the CardioNexus nursing team on weekdays.
* Protocol-driven escalation: Where monitoring identifies potential deterioration, the CardioNexus nurse will conduct a telephone clinical assessment (approximately 15 minutes) and, if required, notify the participant’s treating clinician in accordance with the study escalation protocol. Treating clinicians remain responsible for medical management and respond to alerts within their usual clinical workflow.
* Welfare checks: If participant data are missing or participants become disengaged, the nursing team performs twice-weekly reviews of monitoring data. Participants who have not submitted data or cannot be contacted through routine monitoring will receive a welfare telephone call to confirm wellbeing, troubleshoot barriers to engagement, and encourage continued participation. This service is not an emergency service.
Intervention code [1] 334521 0
Prevention
Intervention code [2] 334522 0
Treatment: Other
Description of the comparator or control
The comparator is usual care delivered by the participant’s treating healthcare providers, including general practitioners, cardiologists, and heart failure services, according to routine clinical practice. Care is delivered through standard face-to-face and telehealth consultations as determined by the treating clinicians. Participants continue to receive their usual management over the 6-month study period while remaining in their home and community setting. No additional intervention, reminders, or monitoring are provided by the study team, and adherence to treatment and follow-up occurs according to standard clinical practice.
Control group
Active

Outcomes
Primary outcome [1] 345907 0
Occurrence of at least one worsening heart failure event, defined as a heart failure-related emergency department presentation or heart failure hospitalisation.
Timepoint [1] 345907 0
Continuously over 6-month from date of randomisation
Secondary outcome [1] 463725 0
Exploratory secondary analysis: GP-supported versus cardiologist-supported pathways
Timepoint [1] 463725 0
6 months after randomisation
Secondary outcome [2] 463726 0
Time to first worsening heart failure event
Timepoint [2] 463726 0
continuous from baseline up to 6 months post randomisation
Secondary outcome [3] 463727 0
Quality of Life
Timepoint [3] 463727 0
Baseline and 6 months post randomisation
Secondary outcome [4] 463728 0
Medication adherence
Timepoint [4] 463728 0
Monthly from baseline up to 6 months post randomisation
Secondary outcome [5] 463729 0
All-cause hospitalisation
Timepoint [5] 463729 0
continuous from baseline up to 6 months post randomisation
Secondary outcome [6] 463730 0
Cardiovascular mortality
Timepoint [6] 463730 0
continuous from baseline up to 6 months post randomisation
Secondary outcome [7] 463731 0
Participant satisfaction and acceptability- this will be assessed as a composite outcome
Timepoint [7] 463731 0
6 months post randomisation

Eligibility
Key inclusion criteria
1. Age greater than 18 years
2. Established diagnosis of chronic HF (HFrEF or HFpEF) documented in the medical record, based on prior clinical assessment consistent with contemporary guidelines
3. Receiving community-based care for HF at the time of enrolment (i.e., not currently an inpatient)
4. Access to a mobile phone or internet-enabled device capable of supporting the mHealth platform (with assistance if required, or study device provided if necessary)
5. Able to provide informed consent in English
6. Willing to participate for the 6-month study duration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants meeting ANY of the following criteria will be excluded:
1. Specialist HF Phenotypes: Participants with known or suspected specialist HF phenotypes requiring disease-specific management pathways, including:
Cardiac amyloidosis
Pulmonary arterial hypertension
Congenital heart disease
Hypertrophic cardiomyopathy
Active myocarditis
2. Advanced HF: Currently listed for heart transplantation/ left ventricular assist device (LVAD) support
3. Planned Procedures: Planned cardiac surgery or advanced interventional procedures within the study's 6-month follow-up period
4. Severe Comorbidity: Life expectancy <6 months unrelated to HF (in the investigator's clinical judgment)
5. Cognitive and Communication Barriers: Cognitive impairment without a capable carer)/ Insufficient English language proficiency
6. Technology Barriers: No access to a smartphone or internet-enabled device
7. Mental Health: Severe mental illness that would prevent safe participation (e.g., active psychosis, severe untreated depression with suicidal ideation)
8. Other Clinical Trials: Enrolled in another interventional clinical trial with overlapping interventions (Participation in observational studies or non-overlapping intervention trials is permitted).
9. Residential Status: Residing in nursing home or residential aged care facility where daily monitoring would be impractical (Retirement villages and independent living facilities are NOT exclusions if participant manages their own care).
10. Geographic Instability: Planning to relocate outside Australia within the 6-month study period
11. Previous Participation: Previously enrolled in this study (participants cannot re-enrol)
12. Investigator Discretion: Any other condition or circumstance that, in the opinion of the investigator, would make participation unsafe or impractical

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence

Participants will be randomised in a 2:1 ratio using stratified block randomisation. Randomisation will be stratified by two factors:
HF phenotype: HFrEF (ejection fraction <40%) versus HFpEF (ejection fraction =50%)
This creates two stratification categories:
1. HFrEF
2. HFpEF
Recent hospitalisation for HF
Less than 90 days
Greater than or equal to 90 days
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 322227 0
Commercial sector/Industry
Name [1] 322227 0
CardioNexus Remote Monitoring Pty Ltd
Country [1] 322227 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CardioNexus Remote Monitoring Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 325133 0
None
Name [1] 325133 0
Address [1] 325133 0
Country [1] 325133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320750 0
Bellberry Human Research Ethics Committee F
Ethics committee address [1] 320750 0
Ethics committee country [1] 320750 0
Australia
Date submitted for ethics approval [1] 320750 0
23/06/2026
Approval date [1] 320750 0
31/07/2026
Ethics approval number [1] 320750 0
2026-06-1060

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

Contacts
Principal investigator
Name 151494 0
Ms Racheal Watt
Address 151494 0
CardioNexus Remote Monitoring Pty Ltd. Suite 2.01, 176 Wellington Pde East Melbourne, VIC 3002
Country 151494 0
Australia
Phone 151494 0
+61402539889
Fax 151494 0
Email 151494 0
[email protected]
Contact person for public queries
Name 151495 0
Asmita Dalal
Address 151495 0
CardioNexus Remote Monitoring Pty Ltd. Suite 2.01, 176 Wellington Pde East Melbourne, VIC 3002
Country 151495 0
Australia
Phone 151495 0
+61 412751131
Fax 151495 0
Email 151495 0
[email protected]
Contact person for scientific queries
Name 151496 0
Racheal Watt
Address 151496 0
CardioNexus Remote Monitoring Pty Ltd. Suite 2.01, 176 Wellington Pde East Melbourne, VIC 3002
Country 151496 0
Australia
Phone 151496 0
+61402539889
Fax 151496 0
Email 151496 0
[email protected]

Data sharing statement
Will the study consider sharing 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.