RecruitingPhase 2ACTRN12625000463471

Triggered Acute Risk Prevention (TARP): Effect of a Novel Model of Care on Cardiovascular and Mental Health Outcomes.

Triggered Acute Risk Prevention (TARP): Effect of A Novel Model of Care on Cardiovascular and Mental Health Outcomes in Patients with Risk Factors for, or Known Cardiovascular Disease


Sponsor

Northern Sydney Local Health District

Enrollment

120 participants

Start Date

Jul 18, 2025

Study Type

Interventional

Conditions

Summary

Cardiovascular disease (CVD) remains Australia’s leading cause of death. Current prevention strategies focusing on chronic risk factors and daily treatment fail to fully explain the risk of CVD. We and others have identified acute triggers in almost half of heart attacks, yet until now, this information has not been used for prevention. In a placebo-controlled double-blind study of 120 participants with cardiovascular disease (CVD) or >=2 risk factors, we will evaluate a Triggered Acute Risk Prevention (TARP) strategy for the triggers of acute emotional stress (anger and anxiety), physical exertion, heavy/fatty meals, respiratory infection and pollution. The TARP strategy will empower individuals to recognise these triggers and respond appropriately by taking preventative medication and/or accessing app-based trigger-related educational resources. The goal is to lower acute psychological stress responses and to reduce cardiovascular risk.


Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Inclusion Criteria5

  • Age >=40 years with >=2 risk factors or known cardiovascular disease.
  • Risk factors: hypertension, hypercholesterolemia, current smoker, diabetes, positive family history (parents or siblings), atherosclerosis on CT coronary angiogram.
  • atherosclerosis on CT coronary angiogram.
  • History of Takotsubo cardiomyopathy, SCAD, Ischemic stroke, TIA, stenosis>25% on carotid ultrasound.
  • Ownership of a smartphone (capable of downloading the study app).

Exclusion Criteria13

  • Known contraindication or allergy to aspirin.
  • Known contraindication or allergy to beta blocker medications.
  • Current continuous use of anti-platelet drug or anticoagulant besides aspirin.
  • Current treatment with a beta blocker or other heart rate lowering drug or anti-arrhythmic.
  • Current clinical diagnosis of atrial fibrillation.
  • Current heart rate <55bpm OR blood pressure <110/70mmHg.
  • Current diagnosis of anaemia (haemoglobin level below the normal for the gender of participant - Hb<125g/L in men, <115g/L in women).
  • Current, recurrent or previous condition with a high risk of / active major bleeding (eg cerebral aneurysm or cerebral AV malformation, gastrointestinal malignancy, recent peptic ulcer, liver disease, oesophageal varicosities, uraemia, aortic aneurysm, GI bleeding, intracerebral bleeding).
  • Unstable diabetes or asthma.
  • Newly diagnosed mental health illness (within last 3 months); exacerbation of known mental illness (within last 3 months); change of medication or modification in dose for mental illness (within the last 3 months).
  • Cognitive impairment.
  • Currently pregnant or planning to fall pregnant within study period (next 6 months).
  • Investigator discretion.

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Interventions

An in-person appointment will be scheduled with site research nurse and potential participant, at which eligibility criteria will be confirmed, informed consent obtained and baseline characteristics a

An in-person appointment will be scheduled with site research nurse and potential participant, at which eligibility criteria will be confirmed, informed consent obtained and baseline characteristics and assessment performed. A one-month run-in phase shall commence following this appointment, with simulated medication administration and trigger entry in study app. Participant contacted weekly during this period, and data reviewed at three weeks (max four) for adherence. Suitable participants able to continue to randomised study phase. Suitable participants will be randomly allocated to TARP active or placebo intervention. TARP Active At the time, or after a participant experiences a trigger event, they will enter the following details into the study App, and be directed to respond according to the trigger severity level entered: 1. Trigger type (acute anger, emotional stress, heavy exertion, heavy meals, respiratory infection, or pollution) and severity 2. Cause of trigger 3. Date and Time of triggering event 4. Current heart rate at time of entering trigger 5. Medication taken, date and time taken (if medication required according to severity entered) If level of risk is above a pre-set threshold, the App will direct the participant to take the study medicines: • Blue packet containing propranolol and aspirin for acute anger, emotional stress and heavy exertion, • Yellow packet containing aspirin for heavy meals, respiratory infection and pollution. Medication Dosage and Route of Administration TARP active dosage is: Propranolol 10mg orally and Aspirin 100mg orally as required, with one repeat dosage allowed 4 hours or more after first dose, to a maximum of 2 doses per day, OR Aspirin 100mg orally as required, once per day. Participants will receive a follow-up reminder at 2 hours post medication administration (according to the time taken entered at step 5 above). They will be asked to enter their current heart rate and current rating of trigger severity at time of entering follow-up. The approximate duration of time taken to engage with the study app on each occasion should be 5 minutes or less. If level of risk is below a pre-set threshold, the App will direct the participant that: "This level of (trigger name) does not require study medication or need to be entered into the App. If your level of (trigger name) increases please re-assess the trigger using the App as your medication requirement may change. We recommend you visit the Education Portal for useful information on managing anger and wellbeing." Adherence will be monitored by the Investigators through the App Management console, with app analytics evaluated for all data captured during participant trigger entry (steps 1-5). In addition, monthly phone interviews will be conducted by Research Nurse with study participants to collect information on participant experiences. The study consists of a one-month run-in phase, and a 6-month active randomised (medication or placebo) study period.


Locations(3)

Royal North Shore Hospital - St Leonards

NSW, Australia

Westmead Hospital - Westmead

NSW, Australia

North Shore Private Hospital - St Leonards

NSW, Australia

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ACTRN12625000463471


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