Echocardiography in Men With Erectile Dysfunction

Sponsor

Herlev and Gentofte Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05285280

Collaborator

(none)

355

Enrollment

Location

125

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Cardiovascular Diseases Cardiac Disease	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

355 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2032

Outcome Measures

Primary Outcome Measures

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 [1 year]
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Number of reported peripheral artery disease through medical records [5 years]
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Number of reported peripheral artery disease through medical records [10 years]
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Number of reported coronary heart disease through medical records [1 year]
Registration of: Coronary angiography
Number of reported coronary heart disease through medical records [5 years]
Registration of: Coronary angiography
Number of reported coronary heart disease through medical records [10 years]
Registration of: Coronary angiography
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

Number of reported all cause mortality [1 year]
Number of reported all cause mortality [5 years]
Number of reported all cause mortality [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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