Echocardiography in Men With Erectile Dysfunction

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05285280
• Other study ID #: EDcard
• Status: Active, not recruiting
• Start date: March 1, 2022
• Est. completion date: March 1, 2032

Study information

• Verified date: January 2024
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 386
• Est. completion date: March 1, 2032
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiovascular Diseases
• Erectile Dysfunction
• Heart Diseases

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Denmark	Urological Research Unit	Herlev	Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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