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Echocardiography in Men With Erectile Dysfunction

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05285280
Enrollment
386
Registered
2022-03-17
Start date
2022-03-01
Completion date
2032-03-01
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Cardiovascular Diseases, Erectile Dysfunction

Keywords

Echocardiography, 3D Echocardiography, Strain Rate Imaging, Tissue Doppler, Speckle Tracking

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.

Interventions

DIAGNOSTIC_TESTEchocardiography

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.

Sponsors

Herlev and Gentofte Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men above 40 years old diagnosed with ED will be eligible to participate if none of the

Exclusion criteria

below are present.

Design outcomes

Primary

MeasureTime frameDescription
Number of reported ischemic heart disease through medical records1 year
Number of reported cardiac arrest through medical records1 year
Number of reported hospital admission with heart failure through medical records1 year
Number of reported peripheral artery disease through medical records1 yearRegistration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Number of reported coronary heart disease through medical records1 yearRegistration of: Coronary angiography
Number of reported hospital admission with acute myocardial infarction through medical records1 year
Number of reported angina pectoris through medical records1 year

Secondary

MeasureTime frame
Number of reported all cause mortality1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026