Heart Palpitations and AFIB in Older Men on Testosterone: Signals from TRAVERSE

Heart palpitations and AFIB (Atrial Fibrillation) risk in older men using testosterone is examined in the video below.

Highlights
[⚠️] Testosterone use in older men and its link to heart palpitations and AFIB.
[] Research findings suggest a potential association between testosterone therapy and heart rhythm disturbances.
[] Discussion about the need for cautious testosterone administration in older male patients.
[⚙️] Insights into the mechanisms through which testosterone might impact heart health.
[] Examination of existing studies to assess the credibility of the testosterone-heart health connection.
[] Importance of monitoring heart health during testosterone treatment for older men.

Heart Palpitations and AFIB in Older Men on Testosterone.webp


Is Testosterone Replacement Therapy Safe for the Heart?​


A Critical Look at the Traverse and TOM Trials​


Presented by Nelson Vergel, Founder of ExcelMale.com & DiscountedLabs.com




Introduction​


Hello everyone, Nelson Vergel here from ExcelMale.com and DiscountedLabs.com. Today I want to discuss two important studies that explore the impact of testosterone replacement therapy (TRT) on the cardiovascular system:


  1. The Traverse Study (2023)
  2. The TOM Trial (published ~13 years ago)

As the author of two books on hormones and a long-time advocate for the safe use of TRT, I feel compelled to analyze these studies closely. While the results are promising in many ways, they also raise concerns that haven’t been thoroughly addressed. My hope is that this will inspire more independent investigations.




Background: Changing Views on Testosterone Safety​


The Endocrine Society, as of June 2023, concluded that TRT does not increase cardiovascular risk in men—a significant reassurance after years of controversy, especially following two flawed studies in 2013–2014 that had suggested the opposite.


The Traverse study stands out due to its scientific rigor and the high regard of the researchers involved. However, I want to highlight nuances in both the Traverse and TOM studies that still leave us with questions.




The TOM Trial: Testosterone in Older Men​


Study Overview​


  • Conducted: ~2008–2010
  • Participants: 209 frail men, average age 74, with low testosterone and limited mobility
  • Intervention: AndroGel (1%) vs placebo
  • Objective: Measure improvements in muscle strength and mobility

Key Findings​


  • Improvements in leg and chest strength, and stair-climbing ability
  • However, the Data Safety Monitoring Board (DSMB) halted the study in December 2009 due to a higher rate of cardiovascular events in the testosterone group:
    • 29 events vs 5 in placebo group

What Counts as a "Cardiovascular Event"?​


This study included both fatal and non-fatal events, such as:


  • Peripheral edema (swelling)
  • Hypertension
  • Arrhythmias
  • Syncope (fainting)
  • Heart attacks and worsening atrial fibrillation (AFib)

Even after adjusting for baseline risks like high cholesterol and diabetes, the negative effect persisted months after treatment ended.




The Traverse Study: A More Recent Look at TRT Safety​


Study Design​


  • Published: 2023
  • Participants: 5,246 men, aged 45–80, with low testosterone (<300 ng/dL) and at least one symptom of hypogonadism
  • All had pre-existing or high risk of cardiovascular disease
  • Treatment: AndroGel 1.62% or placebo
  • Duration: Up to 48 months, with testosterone levels maintained between 350–750 ng/dL
  • Primary outcome: Combined rate of cardiovascular death, non-fatal heart attacks, and non-fatal strokes

Main Conclusions​


  • No significant difference in major adverse cardiovascular events (MACE) between TRT and placebo
  • TRT deemed non-inferior to placebo for cardiovascular safety

Red Flags in the Data​


However, some secondary outcomes were noteworthy:


  • Arrhythmias requiring intervention:
    • 5.2% in TRT group vs 3.3% in placebo (p=0.001)
  • AFib cases:
    • 91 (TRT) vs 63 (placebo)
  • Acute kidney injury and urinary retention were slightly elevated
  • Most significant adverse events were non-fatal

The rise in arrhythmias was statistically significant and cannot be overlooked, especially in older, high-risk men.




Lingering Questions That Need Answers​


  1. Are testosterone injections riskier than gels?
    Most studies—including Traverse and TOM—use gels, but injections are more common in the real world, especially among users on ExcelMale.com.
    • Injections tend to raise hematocrit levels more quickly
    • We need a direct comparison study of gels vs. injections
  2. Does elevated hematocrit contribute to cardiovascular risk?
    • Some evidence (e.g., Dr. Swerdloff and Dr. Amory) suggests a hematocrit >52% may increase risk of fatal/non-fatal cardiovascular events
    • Yet, no large-scale study has directly investigated this
  3. Should older men with hypertension or AFib be monitored more closely on TRT?
    • Based on both studies, yes
    • Especially during the first six months, when side effects like water retention and increased blood pressure are most likely to appear
  4. What causes increased arrhythmias—neurological stimulation or blood viscosity?
    • This remains unclear
    • Future research should involve neurologists, cardiologists, and hematologists to explore this in depth



Final Thoughts​


Despite these concerns, I still believe TRT can be safe when:


  • Properly monitored
  • With regular labs (especially hematocrit, HDL, and blood pressure)
  • Adjusted for individual risk profiles

That said, we must keep challenging assumptions and demanding better data. I plan to host a roundtable discussion on these questions and will be interviewing Dr. Kara from Baylor this September to dive deeper into the Traverse findings.


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Last edited:
A new study from Dr Ramasamy's team partially answers one of my questions in the video above

(294) Revisiting Risk of Testosterone Therapy: Assessing the Impact of Supratherapeutic Levels on MACE and Mortality

S. Nackeeran, C. Egemba, +1 author R. Ramasamy
Published in Journal of Sexual Medicine 1 February 2024
Medicine


There were no associations with MACE in this population, although overall numbers of death from MACE were low in this data set, and future studies should examine longitudinal data across a greater duration and consider non-fatal MACE events in men who achieve supra-therapeutic levels on TT.

Abstract
The benefits and risks of testosterone therapy (TT) have been a subject of long-standing debate. The recent TRAVERSE trial demonstrated that men who received TT did not show an increased risk of major adverse cardiovascular events (MACE) or mortality. However, it is essential to note that the median post-treatment testosterone levels were found to be less than 400ng/dL. Therefore, our investigation aims to assess whether supra-therapeutic T levels (>1000ng/dL) are associated with an elevated risk of MACE and/or mortality. To use data from the National Health and Nutrition Examination Survey (NHANES) 2011-2016 to determine whether supratherapeutic testosterone levels (> 1000 ng/dL) are associated with higher rates of all-cause mortality or MACE. Additionally, to determine whether there was a higher rate of MACE among patients who died. We collected data from the NHANES 2011-2016 Continuous Files and linked them to the National Death Index (NDI) through 2019. The NHANES is a national survey run by the Center for Disease Control that assesses the health status of United States residents by sampling of populations across the country. The survey collects socio-demographic data, lab values, dietary health, clinical variables and body measurements. NDI is a centralized database of United States death record information on file in state vital statistics offices. We included male participants aged 18 years and older with data on total testosterone and who were eligible for mortality data. We compared participants with testosterone > 1000 ng/dL against those with <1000 ng/dL, with the assumption that those > 1000 ng/dL had supratherapeutic levels of testosterone from testosterone therapy. Our primary outcome was mortality, with secondary outcomes of mortality due to MACE. We additionally analyzed association with MACE as the primary cause of mortality among participants who had died. MACE was determined by those who were categorized as dying of “diseases of the heart” or “cerebrovascular diseases.” We used binary logistic regression and controlled for age, race, body mass index, and history of myocardial infarction. Statistical significance was assessed at p<0.05. All analyses were performed on STATA MP 17. We identified 7,790 males aged 18 or older with mortality data. Of those, 7,715 had testosterone <1000 and 75 men had testosterone > 1000. Among all patients in our cohort, 643 died of all causes, and 199 died of MACE. In the multivariable logistic regression adjusted for potentially confounding variables, we found testosterone >1000 was associated with all-cause mortality (OR 2.59, 95% CI 1.29-5.20, p=0.007). There was no association with mortality from MACE in either all participants (OR 0.60, 95% CI 0.08-4.45, p=0.615) or among those who died (OR 0.28, 95% CI 0.03-2.17, p=0.221). Supratherapeutic levels of testosterone are associated with all-cause mortality by 2019 in NHANES participants from 2011-2016. There were no associations with MACE in this population, although overall numbers of death from MACE were low in this data set. Future studies should examine longitudinal data across a greater duration and consider non-fatal MACE events in men who achieve supra-therapeutic levels on TT.

high testosterone mortality.webp
 
Summarized transcript from my video:

Testosterone Replacement Therapy and Cardiovascular Risk​

Presented by Nelson Vergel – ExcelMale.com & DiscountedLabs.com

Introduction​

Hello everyone, Nelson Vergel here from ExcelMale.com and DiscountedLabs.com. Today, I’ll be discussing two important clinical trials that examine the cardiovascular effects of testosterone therapy:
  • The TRAVERSE Study (2023)
  • The TOM Trial (published 13 years ago)
As many of you know, I’m the author of two books focused on hormone health, and I’m a strong advocate for the safe use of testosterone replacement therapy (TRT). However, these two studies raised some concerns—especially around certain details that haven’t been widely addressed.

Background: Testosterone and Heart Health​

Historically, testosterone therapy faced scrutiny, especially around 2013–2014 due to two flawed studies suggesting an increased cardiovascular risk. Since then, many higher-quality trials have refuted those conclusions. The most recent and rigorous is the TRAVERSE Study, which found no increase in cardiovascular risk with TRT.

The TOM Trial (Testosterone in Older Men)​

Study Overview​

  • Year: Conducted from 2008 to 2010
  • Participants: 209 frail men, average age 74
  • Conditions: Low testosterone, limited mobility
  • Design: Randomized to receive either AndroGel or placebo
  • Goal: Evaluate improvement in strength and physical function

Findings​

  • Testosterone improved leg strength, chest strength, and stair-climbing ability
  • However, the treatment phase was halted early (Dec 2009) due to increased cardiovascular events

Cardiovascular Events​

  • Testosterone Group: 29 events
  • Placebo Group: 5 events
  • Events included edema, high blood pressure, arrhythmias, and fainting—not necessarily heart attacks or strokes.
  • Concern: Even after adjusting for baseline conditions like hypertension or diabetes, the testosterone group had more events.

The TRAVERSE Study (2023)​

Study Overview​

  • Goal: Assess major cardiovascular safety of TRT
  • Participants: 5,246 men aged 45–80 with low testosterone (<300 ng/dL) and existing cardiovascular disease
  • Design: Double-blind, randomized
    • TRT Group: AndroGel 1.62%
    • Placebo Group
    • Follow-up: 48 months
    • Testosterone levels kept between 350–750 ng/dL
    • Hematocrit levels kept below 54%

Primary Outcomes​

  • No significant difference in major adverse cardiovascular events (MACE):
    • Death
    • Non-fatal heart attacks
    • Non-fatal strokes
Result: TRT was non-inferior to placebo, confirming safety in terms of major events.

Secondary Outcomes: Key Concerns​

While the overall safety profile was positive, several non-fatal cardiovascular signals emerged:
ConditionTRT GroupPlacebo GroupP-value
Non-fatal arrhythmias requiring intervention134870.001
Atrial fibrillation (AFib)91630.02
Acute kidney injury60400.04
Urinary retention50340.08
These findings suggest an increased risk for palpitations and arrhythmias in the testosterone group, particularly in older men with pre-existing conditions.

Key Unanswered Questions​

  1. Do testosterone injections pose a greater cardiovascular risk than gels or creams, particularly regarding hypertension and arrhythmias?
    Most studies, including TRAVERSE and TOM, used AndroGel. Yet, in real-world use—especially on ExcelMale.cominjections are far more common. They're affordable, effective, and preferred by most men in my community.
  2. What is the role of elevated hematocrit in cardiovascular events?
    While TRT increases red blood cell production (and hematocrit), no large studies have directly linked this to fatal or non-fatal cardiovascular outcomes. We need dedicated research here.
  3. Should older men with hypertension or AFib be monitored more closely on TRT?
    Absolutely. Especially during the first six months of therapy when water retention, blood pressure spikes, and AFib symptoms are most likely to emerge.
  4. Are the observed non-fatal cardiovascular events in TOM and TRAVERSE due to:
    • Increased blood viscosity?
    • Neurological stimulation?
    • Or other mechanisms?
    This is a critical area for future research. I'd love to see neurologists, hematologists, and cardiologists dive into these mechanisms in a roundtable format.

Final Thoughts​

Despite the noted side effects, I still believe testosterone therapy is safewhen properly monitored. That includes:
  • Regular blood work
  • Monitoring hematocrit, blood pressure, and HDL cholesterol
  • Careful assessment in older men with comorbidities
These two landmark studies provide valuable insight but also raise questions we must keep exploring.

Stay Connected​

Thank you for watching—and stay tuned for more.
 
Did they measure only daily through with the gel in traverse study?
Yes, only nadirs.

Testosterone levels in the TRAVERSE trial were measured at the nadir during therapy (24 hours after the last dose). Nadir levels are 30 to 40% lower than the peak levels 2 to 8 hours after gel application.
 
After matching, 10,511 men who experienced an any increase in Hct after initiating TTh and an equal number of controls who did have an increase in Hct were included. Compared to controls who did not have an increase in Hct after starting TTh, the men who had an increase in subsequent Hct had a significantly increased risk of MACE compared to men with no change in Hct.

 

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