EndoPAT Device for Endothelial Dysfunction in ED

University of California Irvine (UCI)

Status: Enrolling

Conditions: Endothelial Dysfunction; Erectile Dysfunction; Hypogonadism, Male

Treatments: Drug: Daily low-dose PDE5 inhibitor therapy; Drug: Testosterone therapy as per clinical guidelines.

Study type: Interventional

Funder types: Other

Identifiers

NCT06720597

5526

Details and patient eligibility

About

To assess endothelial dysfunction in young men (aged 30-50) with vasculogenic ED identified through penile Doppler ultrasound.

To evaluate changes in endothelial function using EndoPAT before and 3-6 months after daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy.

To investigate endothelial function alterations in hypogonadal patients before and 3-6 months after initiating testosterone (T) therapy

Full description

Endothelial Dysfunction and Cardiovascular Health: Endothelial dysfunction is characterized by impaired endothelium-dependent vasodilation, which is a critical factor in the development and progression of cardiovascular diseases. The endothelium, the thin layer of cells lining blood vessels, plays a pivotal role in vascular health by regulating blood flow, coagulation, and immune function. When the endothelium is not functioning properly, it can lead to a range of cardiovascular conditions, including atherosclerosis, hypertension, and erectile dysfunction (ED).

Erectile Dysfunction and Endothelial Dysfunction: ED is often an early marker of endothelial dysfunction and cardiovascular diseases. Vasculogenic ED, in particular, is linked to poor endothelial health, where impaired blood flow to the penile tissue results in the inability to achieve or maintain an erection. This condition shares common risk factors with other cardiovascular diseases, such as diabetes, hypertension, and hyperlipidemia, highlighting the interconnected nature of endothelial health and ED.

Hormonal Therapy and Endothelial Function: Testosterone therapy (T therapy) is commonly used to treat hypogonadism in men, a condition characterized by low testosterone levels. Hypogonadism itself is associated with an increased risk of cardiovascular diseases, and testosterone therapy has been shown to have varying effects on endothelial function. While some studies suggest that testosterone may improve endothelial health, others indicate potential risks, necessitating further research to clarify its impact.

Current Gaps in Knowledge:

Prevalence of Endothelial Dysfunction in Young Men with ED: While the association between endothelial dysfunction and ED is established, there is a need for precise data on the prevalence and extent of endothelial dysfunction specifically in young men with vasculogenic ED. Understanding this prevalence can inform targeted treatment strategies.

Impact of PDE5 Inhibitors on Endothelial Function: Phosphodiesterase type 5 (PDE5) inhibitors are a first-line treatment for ED, known to improve erectile function by enhancing blood flow. However, their direct impact on endothelial function over time remains underexplored, particularly in terms of long-term cardiovascular outcomes.

Effects of Testosterone Therapy on Endothelial Health: The influence of testosterone therapy on endothelial function in hypogonadal men is not well understood. There is conflicting evidence on whether testosterone therapy confers cardiovascular benefits or risks, necessitating comprehensive studies to determine its effects.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males 18 years old and above
• Diagnosed with erectile dysfunction or hypogonadism

Exclusion criteria

• Patients without the above criteria

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)

Active Comparator group

Description:

Population: 40 men aged 18 or above years diagnosed with vasculogenic ED. Intervention: Daily low-dose PDE5 inhibitor therapy. Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.

Treatment:

Drug: Daily low-dose PDE5 inhibitor therapy

Testosterone Therapy in Hypogonadal Men

Active Comparator group

Description:

Population: 40 hypogonadal men aged 18 or above Intervention: Testosterone therapy as per clinical guidelines. Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.

Treatment:

Drug: Testosterone therapy as per clinical guidelines.

Vasculogenic ED confirmed by penile Doppler ultrasound

No Intervention group

Description:

Population: 40 men aged 18 or above years diagnosed with vasculogenic ED. Intervention: None Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.