Echocardiography in Men With Erectile Dysfunction

NCT ID: NCT05285280

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 386 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2032-03-01

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.

Conditions

Erectile Dysfunction; Cardiovascular Diseases; Cardiac Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Echocardiography

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emil Durukan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Urological Research Unit

Herlev, Capital Region, Denmark

Countries

Denmark

Other Identifiers

EDcard

Identifier Type: -

Identifier Source: org_study_id