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Active, Not Recruiting

NCT Number: NCT05285280

Echocardiography in Men With Erectile Dysfunction

Cardiovascular disease is the leading cause of morbidity and mortality in the world. To curb disease development, there is, therefore, a need to identify more people at increased risk. This can be done by advanced echocardiography, where the exact contraction pattern and dimensions of the heart are measured.

One group of patients who are already considered to be at increased risk for later development of heart disease are men with erectile dysfunction.

The investigators goal is to study the early detection of cardiac dysfunction in men with erectile dysfunction using both conventional and advanced echocardiography to analyze the possibility of preventing serious cardiovascular disease.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Urological Research Unit

Herlev, Capital Region, 2730, Denmark

About this study

Cardiovascular disease is the leading cause of morbidity and mortality across the globe. About 524,000 Danes live with cardiovascular disease and it affects approx. 56,400 people. In addition, many people live with heart problems without knowing it. These figures emphasize the importance of early identification of more people at increased risk of developing cardiovascular disease to prevent morbidity and mortality.

This can be done using advanced echocardiography, where the heart's precise contraction pattern, as well as structure and dimensions, are measured. One group of patients who are already considered to be at increased risk for later development of cardiovascular disease are men with erectile dysfunction (ED). ED is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Approximately 30% of men over the age of 40 are affected by ED, and the incidence increases with age. ED is thought to be a precursor to cardiovascular disease, where it has been proven that after the onset of erection problems, over 3-5 years, there is an approximately 50% increased risk of cardiovascular disease.

The investigators hypothesize that cardiac structure and function assessed by conventional and advanced echocardiography together with cardiac biomarkers are abnormal in patients diagnosed with erectile dysfunction and can identify patients at high risk for cardiovascular complications. Echocardiography can serve as an important tool in risk assessment in these men who do not necessarily have symptom-causing problems.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men above 40 years old diagnosed with ED will be eligible to participate if none of the exclusion criteria below are present.

Exclusion criteria

  • Patients not able to cooperate
  • Patients unable to understand and sign "informed consent"
  • Previous pelvic surgery (including prostatectomy, cystectomy and rectal surgery)
  • Neurological diseases (e.g. multiple sclerosis, spinal cord injury)
  • ED following pelvic trauma

Treatment and study plan

Echocardiography

Diagnostic Test

The echocardiography will be performed with a GE Vingmed Ultrasoundís Vivid9 (Horten, Norway). All subjects are examined with color TDI, 2-dimensional and M-mode echocardiography, conventional spectral Doppler, 2DSTE, and where possible 4D Echocardiography in the left lateral decubitus position.

Primary outcomes

  1. Number of reported cardiac arrest through medical records

    Time frame: 1 year

  2. Number of reported cardiac arrest through medical records

    Time frame: 5 years

  3. Number of reported cardiac arrest through medical records

    Time frame: 10 years

  4. Number of reported hospital admission with heart failure through medical records

    Time frame: 1 year

  5. Number of reported hospital admission with heart failure through medical records

    Time frame: 5 years

  6. Number of reported hospital admission with heart failure through medical records

    Time frame: 10 years

  7. Number of reported peripheral artery disease through medical records

    Time frame: 1 year

    Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).

  8. Number of reported peripheral artery disease through medical records

    Time frame: 5 years

    Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).

  9. Number of reported peripheral artery disease through medical records

    Time frame: 10 years

    Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).

  10. Number of reported coronary heart disease through medical records

    Time frame: 1 year

    Registration of: Coronary angiography

  11. Number of reported coronary heart disease through medical records

    Time frame: 5 years

    Registration of: Coronary angiography

  12. Number of reported coronary heart disease through medical records

    Time frame: 10 years

    Registration of: Coronary angiography

  13. Number of reported hospital admission with acute myocardial infarction through medical records

    Time frame: 1 year

  14. Number of reported hospital admission with acute myocardial infarction through medical records

    Time frame: 5 years

  15. Number of reported hospital admission with acute myocardial infarction through medical records

    Time frame: 10 years

  16. Number of reported angina pectoris through medical records

    Time frame: 1 year

  17. Number of reported angina pectoris through medical records

    Time frame: 5 years

  18. Number of reported angina pectoris through medical records

    Time frame: 10 years

  19. Number of reported ischemic heart disease through medical records

    Time frame: 1 year

  20. Number of reported ischemic heart disease through medical records

    Time frame: 5 years

  21. Number of reported ischemic heart disease through medical records

    Time frame: 10 years

Secondary outcomes

  1. Number of reported all cause mortality

    Time frame: 1 year

  2. Number of reported all cause mortality

    Time frame: 5 years

  3. Number of reported all cause mortality

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Official study title

Prevalence and Risk Factors Associated With Cardiovascular Comorbidity in Men With Erectile Dysfunction

Important dates

Study start
2022
Primary completion
2024
Study completion
2032
First posted
Mar 17, 2022
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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