Testosterone Therapy and Heart Health: What Current Evidence Says
Written by the Innovative Men's Health Editorial Team
Medically reviewed by Alessa Lopez-Castor, ARNP, DNP
Last medically reviewed: September 18, 2026
Few men’s-health questions generate as much heat as testosterone therapy and heart health. Online claims often swing between “TRT is safe for everyone” and fear-based headlines. Neither extreme matches how clinicians interpret the evidence.
This educational guide explains how the evidence has evolved, including the TRAVERSE cardiovascular outcomes trial, FDA labeling updates, and guideline-aligned evaluation and monitoring. It does not diagnose you, provide dosing instructions, or guarantee any cardiovascular or hormone outcome.
Why the TRT–heart conversation has been complicated
For years, observational reports and conflicting studies left uncertainty about whether testosterone replacement therapy increases major cardiovascular events such as heart attack, stroke, or cardiovascular death. In 2015, the U.S. Food and Drug Administration required manufacturers of approved testosterone products to conduct clinical trials addressing cardiovascular safety. TRAVERSE was designed to help answer that question in men with documented hypogonadism who already had cardiovascular disease or elevated cardiovascular risk.
Even before TRAVERSE, the Endocrine Society’s clinical practice guideline advised against starting testosterone therapy in men with uncontrolled heart failure, myocardial infarction or stroke within the previous six months, thrombophilia, elevated hematocrit, untreated severe obstructive sleep apnea, and several prostate- or fertility-related contraindications. Shared decision-making remains central.
What TRAVERSE reported
TRAVERSE enrolled more than 5,000 men ages 45–80 with symptoms of hypogonadism, two fasting testosterone levels below 300 ng/dL, and either preexisting cardiovascular disease or high cardiovascular risk. Participants received daily transdermal testosterone gel or placebo. Mean treatment duration was about 22 months, with mean follow-up of about 33 months.
Primary finding. Major adverse cardiac events—cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke—occurred in 7.0% of the testosterone group and 7.3% of the placebo group (hazard ratio 0.96; 95% CI 0.78–1.17). The trial met its prespecified noninferiority criterion for this endpoint.
Other signals. The study also observed higher incidences of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group. Noninferiority for the primary cardiac endpoint does not mean there are no cardiovascular or clotting considerations.
Important limits. TRAVERSE studied symptomatic men with confirmed low testosterone and cardiovascular disease or elevated risk, using gel under protocol monitoring. It did not study recreational use, every formulation in every setting, or guarantee safety for every individual.
FDA labeling themes after TRAVERSE
In February 2025, the FDA announced class-wide testosterone labeling changes after reviewing TRAVERSE and required ambulatory blood-pressure monitoring studies. The changes included:
Adding TRAVERSE results to product labeling.
Removing prior boxed-warning language that framed an increased risk of adverse cardiovascular outcomes.
Retaining limitation-of-use language for age-related hypogonadism; testosterone products remain indicated for specific hypogonadism diagnoses, not as general anti-aging treatment.
Emphasizing that testosterone products can increase blood pressure, which can raise cardiovascular risk over time.
Labels also address venous thromboembolism and other known risks. Review the Medication Guide for your specific product with a licensed clinician rather than creating do-it-yourself rules from headlines.
Evaluation, risk factors, and monitoring
A careful conversation starts with whether therapy is appropriate: consistent symptoms, appropriately confirmed low morning testosterone, and review of contraindications and competing diagnoses. Cardiovascular history—including prior heart attack or stroke, heart-failure control, blood pressure, clotting history, smoking, diabetes, cholesterol, and sleep apnea—belongs in that evaluation. Cardiology consultation may be appropriate in some cases.
When therapy is considered or underway, clinician-directed monitoring commonly includes:
Symptoms, adherence, treatment response, and adverse effects.
On-treatment testosterone levels, interpreted for the assay and formulation—not self-dosing from internet charts.
Hematocrit at baseline and during follow-up; markedly elevated hematocrit, often discussed around greater than 54%, warrants reassessment.
Blood pressure monitoring, consistent with current FDA labeling.
Prostate-related shared decision-making, including PSA discussion when appropriate.
Formulation-specific counseling and review of rhythm or clotting concerns.
Monitoring supports safer care; it does not make therapy appropriate or risk-free for everyone.
Considering treatment? Learn how testosterone therapy is evaluated at IMHS.
Putting the evidence in perspective
In TRAVERSE’s studied population, testosterone gel was noninferior to placebo for major adverse cardiac events.
Atrial fibrillation, pulmonary embolism, acute kidney injury, and blood-pressure increases still warrant individualized discussion.
Guidelines advise against starting TRT in several high-risk cardiac and clotting contexts.
Treating documented hypogonadism is not the same as treating heart disease, and TRT is not a substitute for cardiovascular risk reduction.
Bring questions to a clinical visit rather than starting, stopping, or changing therapy based on social media.
Care at IMHS Bellevue—and eligible Washington telehealth
At Innovative Men's Health, testosterone replacement therapy begins with history, appropriate labs, and a no-pressure discussion of benefits, uncertainties, and monitoring—not a rush to prescribe. Browse our services, contact the clinic, or learn about Washington telehealth for eligible adults when clinically suitable.
Innovative Men's Health is located at 1940 116th Ave NE Unit 201, Bellevue, WA 98004. Phone: (425) 455-1700. Evaluation comes first; results vary; treatment is individualized when clinically appropriate. Inquiry does not equal a prescription or guarantee treatment.
Key takeaways
Avoid both “TRT is safe for everyone” and fearmongering; the evidence is nuanced and continues to evolve.
TRAVERSE reported 7.0% versus 7.3% for major adverse cardiac events (HR 0.96; 95% CI 0.78–1.17), meeting noninferiority criteria.
TRAVERSE also noted higher atrial fibrillation, pulmonary embolism, and acute kidney injury in the testosterone group.
FDA labeling now incorporates TRAVERSE findings while emphasizing blood-pressure and other precautions.
Structured evaluation and monitoring remain essential.
Frequently asked questions
Does testosterone therapy cause heart attacks?
TRAVERSE did not show an increase in the primary major-adverse-cardiac-event composite versus placebo in its studied population. That is not a promise that TRT cannot affect an individual’s risk. Your history and risk factors still matter.
Is TRT safe for everyone with low testosterone?
No. Guidelines recommend against therapy in several circumstances, including recent major cardiovascular events, uncontrolled heart failure, thrombophilia, and other conditions. Suitability must be individualized.
What did the FDA change about testosterone labels?
After reviewing TRAVERSE and blood-pressure studies, the FDA announced class-wide updates adding TRAVERSE findings, removing prior boxed-warning language about increased adverse cardiovascular outcomes, retaining limitations for age-related hypogonadism, and highlighting blood-pressure increases.
What monitoring matters for heart-related safety on TRT?
Plans commonly include clinician-directed testosterone levels, hematocrit, blood pressure, symptom and adverse-effect review, and prostate-related decisions when appropriate, together with attention to clotting and rhythm history.
Is this the same as the ED-and-heart-health topic?
No. Erectile dysfunction and heart health focuses on ED as a possible vascular risk marker. This article focuses on testosterone therapy and cardiovascular evidence.
Sources and further reading
Lincoff AM, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. New England Journal of Medicine. 2023. TRAVERSE; NCT03518034.
American College of Cardiology journal scan summary of TRAVERSE. June 2023.
U.S. Food and Drug Administration. Class-wide labeling changes for testosterone products. February 28, 2025.
Bhasin S, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology & Metabolism. 2018;103:1715–1744.
Keep reading
Monitoring After Starting TRT: What to Expect
TRT, Prostate Health, and PSA Monitoring
Erectile Dysfunction and Heart Health
Monitoring after starting TRT • TRT, prostate health, and PSA monitoring • Erectile dysfunction and heart health
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Medical disclaimer
This article is for general educational information only. It is not medical advice, diagnosis, or treatment; it does not create a clinician–patient relationship; and it does not guarantee eligibility, treatment, or any outcome. Do not start, stop, or change testosterone or any medication without guidance from a licensed clinician who knows your history. Call 911 for chest pain, stroke symptoms, severe shortness of breath, or another medical emergency.
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