Clinical Trials

Study of a medication for uncontrolled or resistant hypertension

BaxHTN Study

Elevated blood pressure (hypertension) is a leading global risk factor for cardiovascular disease, stroke, disability, and death and affects an estimated 1.4 billion persons worldwide.
Individuals with uncontrolled hypertension (uHTN) and resistant hypertension (rHTN) have a substantially increased risk of suffering cardiovascular and renal diseases as they are exposed to the injurious effects of chronically elevated blood pressure in heart, brain, and kidneys.

Uncontrolled hypertension refers to blood pressure that remains higher than goal levels despite being treated with 1 or 2 anti-hypertensive agents.

Resistant hypertension is defined as blood pressure targets not achieved despite the use of at least 3 anti-hypertensive drugs

The purpose of the BaxHTN study is to measure the efficacy and safety of the investigational product known as baxdrostat in participants with uncontrolled hypertension or resistant hypertension.

You may be eligible to take part if you:

• Are 18 + years of age
• Diagnosed with uncontrolled or resistant hypertension and are currently taking 2 or more medications for your blood pressure control.

To find out more, please contact the Research Coordinator Kayla Eldridge on 03 4215 1027 or email [email protected] (Mon – Wed)

This study is approved by St Vincent’s HREC Melbourne.

  

Knee Osteoarthritis Gene Therapy Clinical Trial

The ICM 20-1001 trial is looking to test a potential new gene therapy treatment for osteoarthritis. The potential new treatment is called ICM‑203. The treatment may help to form new cartilage and reduce any inflammation in your knee joint. ICM‑203 is injected directly into the knee joint.

ICM-203 is being tested in a placebo-controlled trial. The purpose of a placebo-controlled trial is to learn more about the safety and how a potential new treatment works, by comparing it to a medication that has no active ingredients (placebo). In this study, there is a 75% chance you will receive the new treatment and a 25% chance you will receive placebo.

You may be eligible to take part if you 

• Are between 50 and 80 years of age
• Have pain associated with mild or moderate knee osteoarthritis

If you take part, you can maintain your usual treatment for symptoms associated with knee osteoarthritis and for other medical problems.

If you are interested in participating, please contact Dr Kirsten Porter, Orthopaedic Research Coordinator, on (03) 4215 2208 or [email protected]

 

Take part in a study about older age and health decisions

How is an older person’s age considered when doctors and older people make decisions about health and wellbeing? We are interested in your experiences and views.

Who can participate?

Doctors or older people (age over 65 or over 50 if an Aboriginal or Torres Strait Islander person) who live within one hour of Geelong. 

What is involved?

A 20-30 minute face to face interview at a location of your choosing

For further information contact Dr Lisa Mitchell via email [email protected].

Barwon Health Ethics Approval Project ID: 23/173

 

Do you suffer from knee osteoarthritis pain and have excess weight to lose?

Barwon Health is currently conducting a clinical trial to examine the use of an investigational medication and its impact on weight management and knee osteoarthritis pain.

You may be eligible to take part in this study if:

• You have a BMI of > 35
• You are aged 18 years or over
• You have knee osteoarthritis pain
• You are not able to lose weight on your own

For more information please contact the Research Nurse, Anne Welsh on 03 4215 2879 or [email protected]

This study has been approved by Monash Health HREC.

 

Do you suffer from Cardiovascular Disease and have excess weight to lose?

Barwon Health is currently conducting a clinical trial to examine the use of an investigational medication and its impact on weight management.

You may be eligible to take part in this study if:

• You have a BMI of > 35
• You are aged 18 years or over
• You have known Cardiovascular Disease (heart attack, stroke or narrowed blood vessels)
• You are not able to lose weight on your own

For more information please contact the Research Nurse, Fahriya Zandari on 03 4215 2877 or [email protected].

This study has been approved by Monash Health HREC

 

Trial to test surgical repair of the torn rotator cuff in the shoulder

The ARC Trial is a clinical trial that will compare arthroscopic shoulder surgery where the rotator cuff tear is repaired, to the same surgery without repairing the rotator cuff. This research project is testing whether surgery to repair the tear is an effective treatment to improve shoulder pain and function and quality of life in people with rotator cuff tears.

You may be eligible to take part in the trial if you:

• Are aged between 45-75 years old
• Have been suffering from shoulder problems for the last six months
• Have been diagnosed as having a reparable rotator cuff tear, which was confirmed by an MRI imaging scan

To find out more, please contact Dr Kirsten Porter, Orthopaedic Research Coordinator, on (03) 4215 2208 or [email protected]

This study has ethical approval from UNSW Human Research Ethics Committee

Trial to explore best method for shoulder replacement surgery

Recruitment is starting soon for the RAPSODI-AUS study, which compares two common types of shoulder replacement: the Total Shoulder (Anatomic) replacement, and the Reverse Shoulder replacement. These are the two types of shoulder replacement that surgeons use very often for patients with osteoarthritis who need a shoulder replacement. They both help to reduce pain and maintain or improve movement, and the aim of this study is to explore which method works best.

You may be eligible to take part in the trial if you:

• Are aged 60 years and over
• Have been diagnosed as having shoulder osteoarthritis
• An intact rotator cuff (determined via pre-operative advanced imaging)

To find out more, please contact Dr Kirsten Porter, Orthopaedic Research Coordinator, on (03) 4215 2208 or [email protected]

This study has ethical approval from Metro North Health Human Research Ethics Committee

 

HARMON-E Study of lifestyle changes for reducing symptoms of depression

What is the HARMON-E study?

The HARMON-E trial is a group-based, telehealth clinical trial designed to support positive lifestyle changes to improve mental health for adults who are experiencing depression or bipolar disorder. HARMON-E is based on well-established evidence for lifestyle interventions as effective strategies for improving depressive symptoms and common associated physical health conditions. 

How are we doing this study?

We are recruiting 378 people (18+) from across Australia to participate in this study. Participants are randomly allocated into one of two programs: 1) led by allied health professionals and 2) led by clinical psychologists. Each program is 8 weeks long and we will measure changes in depressive symptoms over this period and compare them between the two groups.

Participants are asked to: 

• Join one 30-minute one-on-one introductory session with their interventionist via video call (Zoom)
• Join six 90-minute mental health therapy sessions via video call with a group of up to 7 other people (the same group each time)
• Answer questions in 5 one-on-one interviews over zoom about your health and wellbeing
• Make 2 visits to your local pathology to have a blood test and your height and weight measured
• Collect 2 stool samples at home

What are we hoping to find? 
The trial aims to determine whether a lifestyle-based approach to mental health care is as good as psychotherapy for reducing symptoms of depression.

Interested in participating?

If you are interested in participating you can complete a quick, 5 minute online pre-screening survey to see if you may be eligible.
The survey can be found here: HARMON-E Trial prescreening survey (deakin.edu.au)

You can contact the HARMON-E Team at [email protected] or 03 5227 2380
Food & Mood Centre,IMPACT Institute, Deakin University,  www.foodandmoodcentre.com.au

 

Negative symptoms of schizophrenia study

We are currently seeking participants for a study investigating the negative symptoms of schizophrenia

The study will be conducted at the Adrian Costa Clinical Trials Centre in Geelong and consists of a single appointment that includes:

• An interview to discuss your mental health.
• Taking of your blood for later testing.
• Cognitive tasks to assess your memory, attention, and processing speed.
• Measurement of weight, height, and blood pressure.

Inclusion criteria:

• Age 18+ years
• A clinical diagnosis of a psychotic disorder such as schizophrenia, schizophreniform psychosis, schizoaffective disorder, or related disorder.

If you are interested in participating, please email [email protected] or call Research Assistant Marko Milicevic at (03) 5227 2229 for more information.

We are also seeking referrals from clinicians who treat psychotic disorders in the Barwon region.

This study has ethical approval from Barwon Health Human Research Ethics Committee, HREC/79204/VICBH-2022-331357(v3).

 

BOOST-IC COVID-19 Vaccine Study

We are seeking participants for a study looking at COVID-19 booster vaccine responses in the following groups:

• People with HIV
• People who have received a solid organ transplant
• People with haematological malignancies— CLL, Myeloma, non‐Hodgkin Lymphoma

You may receive 1 or 2 doses of Moderna or Pfizer bivalent COVID-19 vaccine.

To find out more, please contact Anne Welsh on 4215 2879 or [email protected]

This research study has ethics approval from the Alfred.

 

Medication trial for methamphetamine use

We are studying whether mirtazapine can help people reduce their meth use.

Visit tinatrial.info for more information or contact Caity on 0432 236 786 or [email protected].

This trial has been approved by the University of Wollongong Human Research Ethics Committee  #2021/ETH12037

   

Victorian Cancer Trials

To view the cancer trials currently underway at Barwon Health, visit the Victorian Cancer Trials Link website.

Searching this website is easy. All you have to do is type information about you, your cancer or cancer treatment to begin. Once you have begun the search, you can narrow your results by selecting criteria on the left hand side of the page.

Once you have found a trial that you think you can join, speak to your doctor or contact the Barwon Health Cancer Services Trials Unit for more information.

 

New clinical trial to prevent Urinary Tract Infections (UTIs)

Barwon Health is currently looking for participants for a clinical trial to prevent Urinary tract infections (UTIs)

Participants would be required to attend several visits over a 3 year period.

You may be eligible if you are:

• Adults aged ≥ 60 years
• Have a history of UTI in the past 2 years
• In generally good health

For more information please call 03 4215 2877 or email [email protected]

This study has been approved by Monash Human Research Ethics Committee

 

Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) Study

This NHMRC study is a joint venture between Deakin University and Barwon Health that aims to improve the understanding of the disorder as well as to look for new treatments for ME/CFS. 

Who can participate?

• Individuals with a diagnosis of ME/CFS
• Individuals with no known disease (healthy controls)
• Male or female, 18-65 years old
• Not currently pregnant
• Not currently enrolled in a clinical trial

Key points for participants

• The study will not involve any costs
• Once enrolled in the study, you will receive a gift voucher up to $40 for any travel costs
• No additional treatment will be provided
• Surveys will be done online at your own pace
• Only ONE appointment needed to take part
• Study involves donating a blood sample

For more information

• https://redcap.link/chromicstudy
• 0352 273 804
• [email protected]

 

Cardiology Research Unit Trials

If you are interested in finding out more about participating in any of our current trials, please contact us at (03) 4215 1033 or [email protected] 

Poseidon:

 Ongoing chronic and systemic inflammation is an important contributor to the risk of recurrent cardiovascular events in patients with established diagnoses of atherosclerotic cardiovascular disease (ASCVD) and/or heart failure (HF). ASCVD and HF are highly comorbid conditions, which are also commonly co-morbid with chronic kidney disease (CKD).

In this research study we will be looking into

• how often people with cardiovascular disease have high levels of inflammation
• if there are common characteristics of patients with high levels of inflammation.

This study will also test the participants for possible risk of kidney or liver disease. This is to see if participants with these co-occurring diseases are more likely to have high levels of inflammation.

You may be eligible if:

• Are 18 + years of age
• Have been diagnosed with blockages in your arteries– legs, heart or neck. Or if you have been diagnosed with heart failure with or without kidney disease

 

BALANCED HF:

We are doing this study to learn about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function. This research also aims to better understand your condition and associated health problems.

• Are 18 + years of age
• Diagnosed heart failure
• Have had a recent admission to hospital due to your heart failure or an urgent outpatient visit with your cardiologist in the past 6 months

 

ACCLAIM Study:

Lp(a) carries cholesterol (a type of fat) in the blood. Elevated levels of Lp(a) can put you at a higher risk of heart disease, stroke, or peripheral artery disease. This research project is testing a potential new treatment for its ability to lower the levels of Lp(a) and hence reduce the risk of major bad effects related to heart disease (for example, heart attack, stroke, or death).

 You are potentially eligible to participate in the study if you fit the following criteria:

• 18 years of age or older with history of heart disease
• or 55 years of age or older who are at risk for the first heart disease

 

HERMES Study

This study will assess the efficacy and safety of ziltivekimab for the treatment of people living with heart failure and inflammation. The study also aims to better understand heart failure and related diseases and how to improve treatment for these conditions.

You may be eligible to take part if you:

• Are 18 + years of age
• Have been diagnosed with heart failure and reduced kidney function

 

EASY AS Study

Your heart valve condition (aortic stenosis, or AS) is a common condition in which one of the four heart valves narrows over many years. When a valve becomes narrow, it can reduce the flow of blood through the heart and the body. Symptoms can include shortness of breath and chest pain; these can take years to develop and some patients never develop symptoms at all.

Patients who do have symptoms can have the valve replaced. This works really well, but as with any medical procedure, there is a chance of complications, and it can take a long time to recover. Some heart specialists believe that replacing the valve before symptoms develop may be better than the more conventional approach of performing the AVR once symptoms develop.

You may be eligible to take part if you:

• Are 18 + years of age
• Have a diagnosis of severe aortic stenosis but no symptoms

  

BaxHTN Study

Elevated blood pressure (hypertension) is a leading global risk factor for cardiovascular disease, stroke, disability, and death and affects an estimated 1.4 billion persons worldwide.
Individuals with uncontrolled hypertension (uHTN) and resistant hypertension (rHTN) have a substantially increased risk of suffering cardiovascular and renal diseases as they are exposed to the injurious effects of chronically elevated blood pressure in heart, brain, and kidneys.

Uncontrolled hypertension refers to blood pressure that remains higher than goal levels despite being treated with 1 or 2 anti-hypertensive agents.

Resistant hypertension is defined as blood pressure targets not achieved despite the use of at least 3 anti-hypertensive drugs

The purpose of this study is to measure the efficacy and safety of the investigational product known as baxdrostat in participants with uncontrolled hypertension or resistant hypertension.

You may be eligible to take part if you:

• Are 18 + years of age
• Diagnosed with uncontrolled or resistant hypertension and are currently taking 2 or more medications for your blood pressure control.