Echocardiography in Men With Erectile Dysfunction
- Conditions
- Erectile DysfunctionCardiac DiseaseCardiovascular Diseases
- Registration Number
- NCT05285280
- Lead Sponsor
- Herlev and Gentofte Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 386
- Men above 40 years old diagnosed with ED will be eligible to participate if none of the exclusion criteria below are present.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of reported peripheral artery disease through medical records 10 years Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Number of reported cardiac arrest through medical records 10 years Number of reported coronary heart disease through medical records 10 years Registration of: Coronary angiography
Number of reported ischemic heart disease through medical records 10 years Number of reported hospital admission with heart failure through medical records 10 years Number of reported hospital admission with acute myocardial infarction through medical records 10 years Number of reported angina pectoris through medical records 10 years
- Secondary Outcome Measures
Name Time Method Number of reported all cause mortality 10 years
Trial Locations
- Locations (1)
Urological Research Unit
🇩🇰Herlev, Hovedstaden, Denmark