Hypertension and Heart Health Trial

Cardiovascular disease (CVD) includes heart disease, stroke, and blood vessel disorders. It remains one of Australia’s biggest health challenges. 1 in 6 Australians (over 4.5 million people) live with CVD. 1 in 4 deaths in Australia are due to CVD—around 120 deaths every day, or one every 12 minutes. Men are 40% more likely to die from CVD than women. Someone is hospitalised for CVD every minute - over 1,500 admissions daily.

The investigational medication or a placebo will be administered via injection under the skin into either the abdomen, thigh or upper arm. It will be administered in clinic, every six months for up to 5 years.

Patients who currently take antihypertensive medications will continue with their treatment. The investigational medication will be an add-on therapy.

This trial aims to improve outcomes for people whose hypertension isn’t controlled by at least two standard medications. Researchers will also look at blood pressure changes, kidney health, and other important measures.

The purpose of the clinical trial is to see if this medication can reduce the risk of serious heart events such as:

• Cardiovascular death
• Heart attack
• Stroke
• Heart failure hospitalisation or urgent visits

Eligible participants will be reimbursed $105 per visit.

Who Can Join?

You may qualify if you:

• Have treated high blood pressure (treated with two or more medications, which must include a fluid tablet (diuretic) and have been on stable treatment), and:

• Are aged 18 or older and have established CVD, such as:

• Coronary artery disease (e.g., prior heart attack, significant artery narrowing, prior stent or bypass surgery), stroke or carotid artery disease or peripheral arterial disease (e.g., prior vascular surgery or amputation) OR

• Are aged 55 or older and are high risk for CVD, with two or more of these or
  • Reduced kidney function (eGFR <60)
  • High urine protein levels
  • Current smoker
  • Atrial fibrillation
  • Coronary calcium score >100
  • NT-proBNP >125 pg/mL
  • Diabetes or high BMI (≥30, or ≥27 if East/Southeast/South Asian)
    
    
• Are aged Aged 70+ with on ore more of these:
  • Reduced kidney function (eGFR <60)
  • High urine protein levels
  • Current smoker
    
  • Atrial fibrillation
  • Coronary calcium score >100
    
  • NT-proBNP >125 pg/mL
  • Diabetes or high BMI (≥30, or ≥27 if East/Southeast/South Asian)

Blood Pressure Requirements

• Systolic BP between 145–179 mmHg at screening and 140–179 mmHg on day 1 (at least 7 days apart).

Participants will be reimbursed up to $1,470 for their time and inconvenience.

This trial will be conducted at our Sippy Downs clinic on the Sunshine Coast.

This trial has been reviewed and approved by an independent Human Research Ethics Committee.

What's Involved?

The trial requires at least 10 clinic visits at our Sippy Downs clinic across 2.5-5 years.

The investigational medication or a placebo will be administered via injection under the skin into either the abdomen, thigh or upper arm. It will be administered in clinic, every six months for up to 5 years.

There is a 50:50 chance of being randomised to receive the investigational medication or placebo.

Procedures

• Physical examinations
• Blood pressure
• Blood samples
• Weight
• Vital signs
• ECG
• Urine samples
• Urine pregnancy test (if required)
• Study drug administration (investigational medication or placebo)

Where Can I Find More Information?

More information can be requested by contacting the recruitment team on 07 5409 8640. Alternatively, the team will be more than happy to answer any questions you may have when they call.