ANZCTR search results

Sodium Glucose Co-transporter 2 inhibitors (SGLT2i) have been shown to reduce cardiovascular morbidity, mortality and have reno-protective effects. Though their glycosuric effects remain the most studied mechanism, multiple other mechanisms of action have been theorized. This includes extra-renal effects on organs such as the brain, heart, and the sympathetic nervous system (SNS). Increased sympathetic tone is a key feature in various conditions such as chronic kidney disease, type 2 diabetes mellitus, obesity, metabolic syndrome, and heart failure. Limiting the renal effects of SGLT2i by administering them to patients who do not produce urine will allow more accurate assessment of their extra-renal impacts and effectiveness in reducing sympathetic nerve activity. This investigator-led, open-label, prospective, mechanistic study aims to investigate the extra-renal effects of SGLT2i on the SNS, by administering empagliflozin to anuric haemodialysis patients and measuring SNS activity using microneurography of the popliteal nerve, over 6 weeks. We hypothesize that the use of empagliflozin will result in reduced sympathetic drive, which in turn would add mechanistic proof to the extra-renal benefits of SGLT2i.

Obesity and physical inactivity are gateway conditions to prevalent and costly cardiovascular (CV) diseases including hypertension, type 2 diabetes, coronary artery disease, stroke and chronic kidney disease. Previous randomised trials have shown promising impacts on weight loss with the use of a self-administered drug called tirzepatide by modifying hormones released from the gastrointestinal tract, as a strategy for the management of obesity. However, an important issue in this and similar studies relates to the type of weight that was lost. In addition to losing fat, participants treated with tirzepatide can lose lean mass, including skeletal muscle. Maintenance of skeletal muscle mass and function are crucial to avoiding frailty, which is linked to cardiovascular diseases and mortality. Resistance exercise training (involving weight lifting type exercises) is known to increase skeletal muscle mass and function in humans, We hypothesise that: -The combination of tirzepatide and a resistance exercise intervention (targeted at reducing fat and increasing skeletal muscle mass), will optimise changes in body composition in our enrolled population, who are at high risk of future cardiovascular diseases. -Combining tirzepatide with exercise training will optimise vascular function and health in older men and women at high risk of future cardiovascular diseases. -Combining tirzepatide with exercise training will optimise heart function in older men and women at high risk of future cardiovascular diseases

The purpose of the study is to provide data demonstrating the safety and effectiveness of the ElectroPulse PFA System for the treatment of atrial fibrillation. In particular, the study will provide first in human insights into clinical safety and device function of the ElectroPulse PFA System for pulmonary vein isolation as a treatment for atrial fibrillation.

Non-invasive ventilation (NIV) is a treatment that uses positive pressure delivered via a face or mouthpiece to assist a person to breathe. It can be used as a long-term treatment for people whose breathing has failed – usually due to chronic conditions that produce weakness of the respiratory muscles (i.e. motor neurone disease [MND] or muscular dystrophy), restriction of chest wall movement (i.e. severe obesity or kyphoscoliosis) or in those with severe loss of lung function (i.e. from emphysema or cystic fibrosis). Most people use this treatment at night to improve their breathing during sleep. If a person is unable to use NIV they can be admitted to hospital overnight to undergo a polysomnography (PSG, “sleep study”) in order to adjust ventilator settings and use NIV more effectively. Previous studies have shown that home-based sleep studies or polygraphies, are both safe and feasible, however it is not known whether patient ventilator synchrony can be optimized similarly to a hospital-based PSG. This study will compare the current hospital admission-based model for adjustment of NIV, with two different home-based models for adjusting NIV therapy, with the goals to improve usage and access to this life sustaining treatment for a vulnerable population. Successful model development will likely also reduce use of acute hospital beds and thus costs.

The primary purpose of the study is to evaluate the safety and tolerability of escalating doses of KER-065 administered as single and multiple subcutaneous doses in healthy adult volunteers.

Commonly used airway devices during general anaesthesia include supraglottic airway devices, of which best practice involves minimising the number of attempts at airway insertion to reduce patient morbidity. The intervention of this study involves the use of two additional pieces of airway equipment, a laryngoscope and bougie, to guide supraglottic guide insertion. The hypothesis is that this insertion method will increase the first attempt insertion success rate.

In this randomised, double-blind, placebo-controlled study, 80 adults experiencing anxiety will be randomly assigned to receive tablets containing either an echinacea extract (EP107) (40mg twice daily) or a placebo for 7 days. We will assess changes in anxiety using the State-Trait Anxiety Inventory and sleep quality using the PROMIS Sleep Disturbance and Sleep-Related Impairment Scale. These questionnaires will be administered at regular times before, during, and 2 weeks after stopping tablet intake.

The purpose of this study is to assess the safety and therapeutic effects (how well a treatment works) of ILYX-002 for the treatment of Dry-Eye Disease. This study will be conducted in patients with Autoimmune Disease, aged 18-85 years old. This study will compare ILYX-002 with vehicle/placebo. A vehicle is a medication with no active ingredients. It looks similar to the real thing, but it is not. One group of participants will receive ILYX-002 and the other group will receive the vehicle/placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive vehicle/placebo. Each group will involve approximately 55 participants, with 110 participants to be enrolled in total.

Social media has transformed communication and during the pandemic has had an alarming influence on public health communication. For example, younger adults and those with greater social media use showed higher endorsement of misinformation and lower support for official health advice provided during the global pandemic in Australia and worldwide. This study aims to develop and assess the effect of an online health literacy intervention on critical appraisal of online information. Participants will receive the intervention either via TikTok-style videos, animated videos, or informative written materials. Outcomes will be compared between the conditions.

We hypothesize that gastric emptying is accelerated to a greater extent when blood sugar falls rapidly compared to slowly. Hypoglycaemia triggers counter-regulatory mechanisms to restore blood sugar by accelerating gastric emptying. It is not known whether the rate of onset of hypoglycaemia impacts gastric emptying acceleration. Accordingly we will study type 1 diabetic patients, and induced either rapid or slow hypoglycaemia using insulin clamps. We will record gastric emptying after a standardised radiolabelled meal. This study may show that slow onset hypoglycaemia requires treatments that bypass the oral route.