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

Herlev and Gentofte Hospital1 site in 1 country386 target enrollmentMarch 1, 2022

ConditionsErectile Dysfunction Cardiovascular Diseases Cardiac Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: Herlev and Gentofte Hospital
Enrollment: 386
Locations: 1
Primary Endpoint: Number of reported cardiac arrest through medical records
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2022

End Date

March 1, 2032

Last Updated

2 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Herlev and Gentofte Hospital

Responsible Party

Principal Investigator

Emil Durukan

Principal Investigator

Herlev and Gentofte Hospital

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