TRT & Heart Health: What the Latest Research Tells Us
For years, one of the most common questions men ask before starting testosterone replacement therapy is whether it's safe for their heart. It's a fair question — and for much of the past decade, the honest answer was that the evidence was conflicting and inconclusive. That has now changed. A landmark 2023 clinical trial has provided the most definitive answer to this question we are likely to see — and the findings offer meaningful reassurance for men with hypogonadism who are considering TRT. Here's what the research shows, what the nuances are, and how Prime Balance approaches cardiovascular safety throughout every TRT protocol.
Why Cardiovascular Safety Became a Concern
The debate over TRT and cardiovascular risk began in earnest around 2010, when a small placebo-controlled trial was discontinued early because of a higher rate of cardiovascular events in men receiving testosterone. In 2015, the FDA responded by requiring manufacturers of approved testosterone therapies to conduct large clinical trials specifically designed to evaluate cardiovascular risk — and issued a label warning about potential cardiovascular effects in the meantime.
What followed was nearly a decade of conflicting findings. Some observational studies suggested increased risk. Others showed cardiovascular benefits — particularly in men with metabolic syndrome, type 2 diabetes, and existing hypogonadism. The medical community was divided, and clinicians were left navigating genuinely uncertain evidence when counseling patients about TRT.
That uncertainty is now largely resolved.
The TRAVERSE Trial — The Most Definitive Answer Yet
In June 2023, results of the TRAVERSE trial were presented at the Endocrine Society's annual meeting and simultaneously published in the New England Journal of Medicine. It is the largest randomized controlled trial ever conducted on TRT and cardiovascular risk — and its findings represent a significant milestone for the field.
The trial enrolled 5,246 men between the ages of 45 and 80 who had either preexisting cardiovascular disease or a high risk of cardiovascular disease — and who had documented hypogonadism with testosterone levels below 300 ng/dL. Participants were randomly assigned to receive either daily testosterone gel or a matching placebo for a mean duration of approximately 22 months, with their testosterone levels carefully monitored throughout.
The primary finding was clear: testosterone replacement therapy did not increase the risk of major adverse cardiovascular events — including heart attack, stroke, or cardiovascular death — compared to placebo. A major cardiac event occurred in 7.0% of the testosterone group versus 7.3% of the placebo group — a difference that was not statistically significant and confirmed the noninferiority of TRT from a cardiovascular standpoint.
The lead investigator from the Cleveland Clinic summarized the significance of the findings this way: the results provide reassurance about the cardiovascular safety of testosterone therapy over the typical duration of treatment in men in whom it is indicated.
What the TRAVERSE Trial Found — The Full Picture
While the headline finding is reassuring, Prime Balance believes patients deserve the complete picture — including the nuances that responsible physicians take seriously.
What the trial confirmed:
TRT does not increase the risk of heart attack, stroke, or cardiovascular death in hypogonadal men
TRT effectively corrected anemia in hypogonadal men — a meaningful secondary benefit given that anemia is itself an established cardiovascular risk factor
Prostate cancer rates were similar between the testosterone and placebo groups
What the trial flagged as areas requiring monitoring:
A higher incidence of nonfatal arrhythmias including atrial fibrillation was observed in the testosterone group compared to placebo
Venous thromboembolic events occurred at a slightly higher rate in the testosterone group
A small increase in acute kidney injury was noted — an unexpected finding that warrants further research
Important context:
These findings apply specifically to men with documented hypogonadism and cardiovascular disease or high cardiovascular risk — not to men using testosterone without a clinical indication
The cardiovascular safety findings are contingent on proper monitoring — the study maintained careful oversight of testosterone levels throughout treatment
Current guidelines recommend that TRT be used with caution in men with a history of thromboembolic events or significant arrhythmias
Why Dr. Forwand's Cardiology Background Matters
The TRAVERSE trial underscores something Prime Balance has always believed: that TRT should never be prescribed without comprehensive cardiovascular assessment and ongoing monitoring. The trial's own investigators emphasized that the safety findings were contingent on careful dose adjustment and regular monitoring of testosterone levels — conditions that are not always met in general practice.
Dr. Forwand brings a Columbia-educated, Harvard-affiliated cardiology background to every TRT protocol at Prime Balance. This means that cardiovascular health is not an afterthought in your hormone optimization journey — it is assessed at baseline, monitored throughout treatment, and integrated into every clinical decision. For patients with preexisting cardiovascular conditions or risk factors, this level of physician oversight is not just preferable — it is essential.
Low Testosterone Itself Carries Cardiovascular Risk
An important dimension of this conversation that is often overlooked is the cardiovascular risk associated with untreated low testosterone. Research has consistently shown that hypogonadism is associated with an adverse metabolic profile — including increased visceral fat, insulin resistance, unfavorable cholesterol levels, and elevated inflammatory markers — all of which are independent risk factors for cardiovascular disease.
The relationship between low testosterone and cardiovascular health is bidirectional and complex. Diseases like diabetes, obesity, and hypertension are established cardiovascular risk factors that are also associated with male hypogonadism — creating a cycle where low testosterone worsens metabolic health, and worsening metabolic health further suppresses testosterone production. Addressing hypogonadism with physician-supervised TRT can help break this cycle — supporting improvements in body composition, insulin sensitivity, lipid profiles, and overall metabolic health that benefit cardiovascular outcomes.
What This Means for Prime Balance Patients
The TRAVERSE trial provides meaningful reassurance — but responsible TRT is never a one-size-fits-all proposition. At Prime Balance, every patient's cardiovascular profile is evaluated before TRT begins, and regular monitoring throughout treatment ensures that therapy remains appropriate, safe, and effective as your health evolves.
If you have questions about TRT and your heart health — whether you have a history of cardiovascular disease, risk factors, or simply want to understand what responsible monitoring looks like — we encourage you to bring those questions to your consultation. The goal is always to make the most informed decision possible based on your individual labs, health history, and goals.
The information in this article is provided for educational purposes only and does not constitute medical advice. The TRAVERSE trial findings referenced apply specifically to men with documented hypogonadism and preexisting or high cardiovascular risk, under conditions of careful clinical monitoring. TRT is prescribed at Prime Balance under physician supervision following comprehensive evaluation of each patient's individual health profile. Always consult a qualified healthcare professional before beginning any new treatment.