Testosterone and Heart Health: Does TRT Increase Cardiovascular Risk?

Cardiovascular safety has been a central question in the testosterone replacement therapy debate for decades. Early observational studies raised concerns; some case reports suggested increased cardiovascular events in men initiating TRT. These concerns led to FDA labeling changes and caused many physicians to hesitate in prescribing testosterone therapy. But the science has evolved dramatically — and the picture now is far more reassuring than the headlines suggested.

The TRAVERSE Trial: The Definitive Answer

In 2023, the TRAVERSE trial — the largest, most rigorous randomized controlled trial of testosterone therapy and cardiovascular outcomes ever conducted — published its results. The trial enrolled over 5,200 men aged 45–80 with low testosterone, hypogonadal symptoms, and pre-existing or high risk for cardiovascular disease, and randomized them to testosterone gel or placebo for an average of 3.5 years. The result: testosterone therapy was non-inferior to placebo for major adverse cardiovascular events (MACE). There was no increased risk of heart attack, stroke, or cardiovascular death in men receiving testosterone therapy.

The TRAVERSE trial essentially resolved the cardiovascular safety debate for appropriately selected patients. Testosterone therapy, at physiological replacement doses in men with documented deficiency, does not increase cardiovascular risk.

Low Testosterone Is the Cardiovascular Risk Factor

The more important story is the reverse: low testosterone is independently associated with increased cardiovascular risk. Men with testosterone deficiency have worse lipid profiles, greater insulin resistance, higher rates of metabolic syndrome, increased visceral fat, endothelial dysfunction, and higher rates of cardiovascular events and all-cause mortality than testosterone-sufficient men. Correcting testosterone deficiency addresses multiple cardiovascular risk factors simultaneously.

One Real Risk: Hematocrit Elevation

One legitimate cardiovascular consideration with TRT is erythrocytosis — elevated red blood cell count and hematocrit. Testosterone stimulates red blood cell production, and in some men, hematocrit rises to levels that increase blood viscosity and theoretically increase thrombotic risk. This is why hematocrit monitoring is standard practice in TRT management. When hematocrit rises above 54%, dose adjustment or therapeutic phlebotomy (blood donation) is recommended. This is an easily managed parameter with appropriate monitoring. At Multigen Wellness, all patients receive regular CBC monitoring. Call +1 (800) 259-0015 for safe, monitored TRT care.