Echocardiography in Men With Erectile Dysfunction

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Erectile Dysfunction; Cardiac Disease
• Intervention / Treatment: Diagnostic test: Echocardiography

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.

• Study Type: Observational
• Enrollment (Actual): 386

Contacts and Locations

Study Locations

• Denmark
  • Hovedstaden
    • Herlev, Hovedstaden, Denmark, 2730
      • Urological Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients will be invited from the Urology outpatient clinic at Gentofte Hospital.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reported cardiac arrest through medical records		1 year
Number of reported cardiac arrest through medical records		5 years
Number of reported cardiac arrest through medical records		10 years
Number of reported hospital admission with heart failure through medical records		1 year
Number of reported hospital admission with heart failure through medical records		5 years
Number of reported hospital admission with heart failure through medical records		10 years
Number of reported peripheral artery disease through medical records	Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).	1 year
Number of reported peripheral artery disease through medical records	Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).	5 years
Number of reported peripheral artery disease through medical records	Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).	10 years
Number of reported coronary heart disease through medical records	Registration of: Coronary angiography	1 year
Number of reported coronary heart disease through medical records	Registration of: Coronary angiography	5 years
Number of reported coronary heart disease through medical records	Registration of: Coronary angiography	10 years
Number of reported hospital admission with acute myocardial infarction through medical records		1 year
Number of reported hospital admission with acute myocardial infarction through medical records		5 years
Number of reported hospital admission with acute myocardial infarction through medical records		10 years
Number of reported angina pectoris through medical records		1 year
Number of reported angina pectoris through medical records		5 years
Number of reported angina pectoris through medical records		10 years
Number of reported ischemic heart disease through medical records		1 year
Number of reported ischemic heart disease through medical records		5 years
Number of reported ischemic heart disease through medical records		10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of reported all cause mortality	1 year
Number of reported all cause mortality	5 years
Number of reported all cause mortality	10 years

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): January 5, 2024
• Study Completion (Estimated): March 1, 2032

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Echocardiography; 3D Echocardiography; Tissue Doppler; Speckle Tracking; Strain Rate Imaging
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Heart Diseases; Cardiovascular Diseases; Erectile Dysfunction
• Other Study ID Numbers: EDcard

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No