Is TRT Safe for Your Heart? The 2026 Evidence (Including the TRAVERSE Trial)
Key Takeaways
For years, conflicting studies left Australian men uncertain about TRT and heart health. The 2023 TRAVERSE trial — the largest TRT safety study ever conducted — finally provides a clear answer.
Why the Concern Arose
The controversy began with a 2010 study by Basaria et al., published in the New England Journal of Medicine, which reported higher cardiovascular adverse events in older men receiving testosterone therapy. The trial was small (n=209) and stopped early — but the signal triggered widespread concern.
In 2013, a retrospective database study by Vigen et al. in JAMA reported increased mortality and cardiovascular events with TRT. It was subsequently criticised for major methodological flaws, but the damage to public perception was done.
The US FDA responded in 2015 by requiring testosterone product labels to carry cardiovascular risk warnings. Australian prescribing tightened accordingly.
The TRAVERSE Trial: The Definitive Answer
Published in the New England Journal of Medicine in July 2023, the TRAVERSE trial is the largest TRT safety study ever conducted.
What it found: Testosterone-replacement therapy was non-inferior to placebo for the incidence of major adverse cardiovascular events — heart attack, stroke, or cardiovascular death — over a median follow-up of 33 months across 5,204 men.
The Cleveland Clinic, which led the TRAVERSE study, concluded: TRT does not increase the risk of major cardiovascular events in men with confirmed hypogonadism, even those with pre-existing cardiovascular disease.
A comprehensive review published in the World Journal of Men's Health (2024) concluded: "TRT to achieve normal ranges of testosterone is safe in terms of cardiovascular and prostate-related events and effective if prescribed according to guidelines."
What TRAVERSE Did Find: Important Nuances
While the primary cardiovascular outcome was reassuring, TRAVERSE identified secondary signals:
Increased non-fatal arrhythmias (including atrial fibrillation): 3.5% in the TRT group vs 2.4% in placebo. Men with pre-existing arrhythmia should discuss this with their GP.
Increased venous thromboembolism: A higher rate of DVT and pulmonary embolism was observed. Men with prior VTE or thrombophilia warrant careful assessment.
Positive metabolic findings: TRAVERSE documented that TRT significantly reduced progression from prediabetes to type 2 diabetes, and corrected anaemia in a substantial proportion of hypogonadal men.
Contraindications to TRT in Australia
Regardless of cardiovascular safety, the following are absolute contraindications:
- Known or suspected prostate cancer
- Known or suspected breast cancer
- Haematocrit >50%
- Severe untreated obstructive sleep apnoea
- Uncontrolled heart failure
References
- Lincoff AM, Bhasin S, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389:107–117.
- Basaria S, et al. Adverse Events Associated with Testosterone Administration. N Engl J Med. 2010.
- Vigen R, et al. Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke. JAMA. 2013.
- Cleveland Clinic — TRAVERSE Study Supports Cardiovascular Safety of TRT.
- FDA Drug Safety Communication — Testosterone Products.
- Endocrine Society of Australia — MJA position statement.
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