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

[Nelson Vergel]

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

Highlights
[] Testosterone use in older men and its link to heart palpitations and AFIB.
[] Research findings suggesting 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.

Remaining Questions About Testosterone and Cardiovascular Events

Would testosterone injections have a more significant negative effect on hypertension and arrythmias in older men than testosterone gels/creams?

What is the role of increased hematocrit in fatal and non-fatal cardiovascular events?

Should older men with hypertension or AFIB given testosterone be monitored more closely?

Is the observed increased incidence of non-fatal cardiovascular events in the two T-gel studies (TOM & TRAVERSE) caused by stimulatory, neurological, or increased blood viscosity effects of TRT?

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[Nelson Vergel]

TRAVERSE: Testosterone and Cardiovascular Safety

www.excelmale.com

 

[Nelson Vergel]

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.

 

[Nelson Vergel]

Association of TRT with Atrial Fibrillation and Acute Kidney Injury

Panken, E1; Greenberg, DR1; Kohn, Md , T2; Asanad, Md , K1; Brannigan, Md , RE1; Halpern, JA1 1 - Northwestern University, Feinberg School of Medicine 2 - The Brady Urologic Institute, Johns Hopkins School of Medicine Introduction: Secondary analyses of the Testosterone Replacement Therapy...

www.excelmale.com

 

[Nelson Vergel]

Summarized transcript from my video:

Testosterone Replacement Therapy and Cardiovascular Risk​

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

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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.

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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.

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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.

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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:

Condition	TRT Group	Placebo Group	P-value
Non-fatal arrhythmias requiring intervention	134	87	0.001
Atrial fibrillation (AFib)	91	63	0.02
Acute kidney injury	60	40	0.04
Urinary retention	50	34	0.08

These findings suggest an increased risk for palpitations and arrhythmias in the testosterone group, particularly in older men with pre-existing conditions.

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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.com—injections 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.

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Final Thoughts​

Despite the noted side effects, I still believe testosterone therapy is safe—when 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.

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• Subscribe to ExcelMale’s YouTube channel
• Join the community at ExcelMale.com
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Thank you for watching—and stay tuned for more.