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NOT YET RECRUITING

NCT07462715

PHASE4

Statins Against Bushfire Smoke

Sponsor: Menzies Institute for Medical Research

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test whether statins can protect the heart and brain from the biological stress and inflammatory responses caused by breathing bushfire smoke in healthy adult volunteers aged 18-64 years. The main questions it aims to answer are: 1. Does short-term statin use (2 days) reduce bushfire smoke-induced changes in heart rate variability, blood pressure, arterial stiffness, inflammation and oxidative stress markers, and cognitive function? 2. Does long-term statin use (≥12 months) reduce bushfire smoke-induced changes in heart rate variability, blood pressure, arterial stiffness, inflammation and oxidative stress markers, and cognitive function? The study includes two streams: Stream 1:short-term statin use (2 days) where participants receive either statin tablets (80mg atorvastatin) or placebo; Stream 2: long-term statin use (≥12 months) where participants include those already taking statins (≥12 months) with statin-naïve individuals. Participants will: * Attend two 3½-hour visits to a Climate Hut, which are approximately 4 weeks apart, where they will spend 2 hours exposed to either filtered air or simulated dilute bushfire smoke (average particulate matter (PM2.5) concentration of 300μg/m\^3) in randomised order; * Have continuous heart monitoring with ECG leads and blood pressure checks every 15 minutes during each visit * Provide urine, saliva, and nose swab samples before and after each exposure, plus follow-up samples the next morning * Complete cognitive tests (reaction time, memory tasks) and postural balance measurements during exposure * Complete questionnaires about anxiety levels, symptoms, diet, and health status * Have blood samples collected and pulse wave velocity measurements (assessing arterial stiffness) immediately after each exposure session. Potential risks include time commitment, muscle pain from statins, eye irritation or throat discomfort from smoke exposure, and minor discomfort from blood collection.

Official title: Does Short-term or Long-term Statin Use Protect the Heart and Brain During Exposure to Bushfire Smoke? A Parallel-group Statin Trial With Cross-over, Order-randomised Smoke Exposure vs Filtered Air Among Healthy Australian Adults.

Key Details

Gender

All

Age Range

18 Years - 68 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-05-01

Completion Date

2028-12-31

Last Updated

2026-03-10

Healthy Volunteers

Yes

Conditions

Healthy Adults

Interventions

DRUG

Atorvastatin

Statin treatment is being investigated to see if it will modify subclinical adverse cardiovascular effects of bushfire smoke. Controlled dilute bushfire smoke is delivered on two occasions 4 weeks apart in a specialist facility. It is order randomised and masked.

DRUG

Placebo

Identical placebo tablets to the atorvastatin tablets used in the intervention group

Inclusion Criteria: * Good general health and, if aged 45 year or more, low to intermediate (\<10%) atherosclerotic cardiovascular disease (ASCVD) risk category, based on clinical data measured within 12 months prior to enrolment. Exclusion Criteria: * History of severe chronic lung diseases such as chronic obstructive pulmonary disease or asthma as determined by participants' care providers. * History of chest pain, irregular heartbeats, heart failure, heart attack, heart pacemaker or coronary bypass surgery. * High cardiovascular risk (\>10%) category on the ASCVD risk calculator or judged to be at high risk by study cardiologist, for those aged 45 years or older. * History of stroke, dementia or other neurological condition * Untreated high blood pressure (≥ 140 systolic, ≥ 90 diastolic) * History of autoimmune or inflammatory rheumatic disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, spondyloarthritis). Osteoarthritis alone is not an exclusion. * History of immunodeficiency * Diabetes (any type) * Current medications: Long term medications that interact with atorvastatin (such as verapamil, digoxin and warfarin); Medications that affect heart rate variability including beta-blockers (such as atenolol, metoprolol, propranolol, and acebutolol), tricyclic antidepressants and selective serotonin reuptake inhibitors (such as amitriptyline, sertraline, fluoxetine or citalopram), or medications with anti-cholinergic action (such as promethazine or prochlorperazine); stimulant medications, such as those prescribed for ADHD (such as methylphenidate, dexamphetamine, lisdexamfetamine); anti-inflammatory, immunosuppressive or immune modulating medications including systemic corticosteroids (such as prednisolone, dexamethasone) and non-steroidal anti-inflammatory drugs (NSAIDS) (such as ibuprofen, naproxen or diclofenac) * Currently smoking, or have smoked: more than one pack of cigarettes in the past year, or have smoked more than 100 packs of cigarettes in their lifetime * Currently vaping or have vaped: more than 200 puffs in the last year, more than 20,000 puffs in their lifetime * Currently pregnant, attempting to become pregnant or breastfeeding * History of skin allergy to tape or electrodes * Inability to travel to the study site

Locations (1)

Menzies Institute for Medical Research

Hobart, Tasmania, Australia