Clinical trial NCT05285280: Echocardiography in Men With Erectile Dysfunction
Official title: Prevalence and Risk Factors Associated With Cardiovascular Comorbidity in Men With Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Erectile Dysfunction
Cardiovascular Diseases
Cardiac Disease
Keywords: Echocardiography
3D Echocardiography
Strain Rate Imaging
Tissue Doppler
Speckle Tracking
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 386
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be invited from the Urology outpatient clinic at 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of reported cardiac arrest through medical records
timeFrame: 1 year
measure: Number of reported cardiac arrest through medical records
timeFrame: 5 years
measure: Number of reported cardiac arrest through medical records
timeFrame: 10 years
measure: Number of reported hospital admission with heart failure through medical records
timeFrame: 1 year
measure: Number of reported hospital admission with heart failure through medical records
timeFrame: 5 years
measure: Number of reported hospital admission with heart failure through medical records
timeFrame: 10 years
measure: Number of reported peripheral artery disease through medical records
timeFrame: 1 year
measure: Number of reported peripheral artery disease through medical records
timeFrame: 5 years
measure: Number of reported peripheral artery disease through medical records
timeFrame: 10 years
measure: Number of reported coronary heart disease through medical records
timeFrame: 1 year
measure: Number of reported coronary heart disease through medical records
timeFrame: 5 years
measure: Number of reported coronary heart disease through medical records
timeFrame: 10 years
measure: Number of reported hospital admission with acute myocardial infarction through medical records
timeFrame: 1 year
measure: Number of reported hospital admission with acute myocardial infarction through medical records
timeFrame: 5 years
measure: Number of reported hospital admission with acute myocardial infarction through medical records
timeFrame: 10 years
measure: Number of reported angina pectoris through medical records
timeFrame: 1 year
measure: Number of reported angina pectoris through medical records
timeFrame: 5 years
measure: Number of reported angina pectoris through medical records
timeFrame: 10 years
measure: Number of reported ischemic heart disease through medical records
timeFrame: 1 year
measure: Number of reported ischemic heart disease through medical records
timeFrame: 5 years
measure: Number of reported ischemic heart disease through medical records
timeFrame: 10 years
Secondary outcomes:
measure: Number of reported all cause mortality
timeFrame: 1 year
measure: Number of reported all cause mortality
timeFrame: 5 years
measure: Number of reported all cause mortality
timeFrame: 10 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Urological Research Unit
state: Hovedstaden
Study officials:
References: