TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

Official title

A Randomized Controlled Trial of Statin Therapy Effect on Androgen Status and Erectile Function in Men With High and Very High Cardiovascular Risk

Overview

Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category. Material and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of cardiovascular diseases and meeting the inclusion criteria. Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg/day. Group Ros (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg/day and/or rosuvastatin to 40 mg/day will be performed if necessary. Patient recruitment to the study will occur over 9 months at a single research center. Patients will be monitored with an objective assessment of erectile function parameters, blood analysis (including androgen status), central arteries stiffness, and endothelial function for 6 months from the moment of activation. Follow-up visits are scheduled at 1, 3 and 6 months. Results. The expected result of testing the research hypothesis is that statin therapy will not have a negative effect on androgen status and erectile function in men. Intensive statin therapy will have a greater positive effect on endothelial function, which may lead to an improvement in men's erectile function. Conclusion. The study was planned under the assumption that statin therapy would not have a negative effect on androgen status and erectile function in men aged 40-65 years. It is also suggested that the positive effect of statins on endothelial function and vascular stiffness may lead to an improvement in erectile function among men with high and very high cardiovascular risk. If the hypothesis is confirmed, the results obtained will help improve statin treatment adherence in male patients and, as a result, increase the effectiveness of prevention of cardiovascular events.

Interventions

• Drug Pitavastatin 1-4 mg daily
  Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg/day will be performed if necessary.
• Drug Rosuvastatin 20-40 mg daily
  Group Ros (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of rosuvastatin to 40 mg/day will be performed if necessary.

Primary outcome measures

• objective assessment of erectile function parameters [Time frame: The assessment is carried out at the time of inclusion in the study, 3 and 6 months after the start of the study]
• androgen status [Time frame: The assessment is carried out at the time of inclusion in the study, 3 and 6 months after the start of the study]

Secondary outcome measures (3)

• central arteries stiffness [Time frame: At the time of inclusion in the study and in dynamics after 3 and 6 months.]
• endothelial function [Time frame: at the time of inclusion in the study and in dynamics after 3 and 6 months.]
• subjective assessment of erectile function parameters [Time frame: The assessment is carried out at the time of inclusion in the study and 6 months after the start of the study]

Eligibility criteria

Inclusion criteria

• male patients aged 40-65 years, sexually active
• high and very high risk of cardiovascular events (The Systematic Coronary Risk Evaluation 2 (SCORE2))
• absence of previous statin therapy for 3 months
• there are no known cardiovascular diseases requiring the appointment of statins in high doses from the start of treatment
• the invariance of concomitant therapy for 3 months, if the patient needs it.

Exclusion criteria

• known statin intolerance
• known hypogonadism
• persistent forms of atrial fibrillation
• active malignant neoplasm requiring treatment at the time of screening
• known chronic inflammatory diseases (rheumatoid arthritis, systemic connective tissue diseases, metabolically associated fatty liver disease, etc.)
• impaired renal function (estimated glomerular filtration rate <30 ml/min/1.73 m2) and liver (transaminase levels more than 3 times reference values, bilirubin levels more than 2 times reference values)
• chronic heart failure
• a well-known diagnosis of mental illness
• alcoholism and drug addiction
• glucocorticoid therapy and regular therapy with nonsteroidal anti-inflammatory drugs (80% of the time for 3 months before switching on)
• participation in any other clinical trial during this trial, including participation in the trial for 30 days prior to providing informed consent
• the patient's inability to understand the essence of the study and consent to participate in it

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Russia · 1 center

• Lomonosov Moscow State University Medical Research and Educational Center Moscow, Moscow R — Moscow

Identifiers

NCT: NCT07460960 · TRISTAN

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗