Erectile DysfunctionNCT05285280
Echocardiography in Men With Erectile Dysfunction
An observational study of Erectile Dysfunction and Cardiovascular Diseases, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Cardiovascular Diseases, Cardiac Disease
- What is being tested?
- Echocardiography
- How many people
- 386 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2022to 1 Mar 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be invited from the Urology outpatient clinic at Gentofte Hospital.
Who may be able to join
- Men above 40 years old diagnosed with ED will be eligible to participate if none of the exclusion criteria below are present.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Echocardiography
- Keywords
- Echocardiography, 3D Echocardiography, Strain Rate Imaging, Tissue Doppler, Speckle Tracking
- Medical subject headings
- Erectile Dysfunction, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reported cardiac arrest through medical records
Measured: 1 year
Number of reported cardiac arrest through medical records
Measured: 5 years
Number of reported cardiac arrest through medical records
Measured: 10 years
Number of reported hospital admission with heart failure through medical records
Measured: 1 year
Number of reported hospital admission with heart failure through medical records
Measured: 5 years
Number of reported hospital admission with heart failure through medical records
Measured: 10 years
Number of reported peripheral artery disease through medical records
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Measured: 1 year
Number of reported peripheral artery disease through medical records
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Measured: 5 years
Number of reported peripheral artery disease through medical records
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Measured: 10 years
Number of reported coronary heart disease through medical records
Registration of: Coronary angiography
Measured: 1 year
Number of reported coronary heart disease through medical records
Registration of: Coronary angiography
Measured: 5 years
Number of reported coronary heart disease through medical records
Registration of: Coronary angiography
Measured: 10 years
Number of reported hospital admission with acute myocardial infarction through medical records
Measured: 1 year
Number of reported hospital admission with acute myocardial infarction through medical records
Measured: 5 years
Number of reported hospital admission with acute myocardial infarction through medical records
Measured: 10 years
Number of reported angina pectoris through medical records
Measured: 1 year
Number of reported angina pectoris through medical records
Measured: 5 years
Number of reported angina pectoris through medical records
Measured: 10 years
Number of reported ischemic heart disease through medical records
Measured: 1 year
Number of reported ischemic heart disease through medical records
Measured: 5 years
Number of reported ischemic heart disease through medical records
Measured: 10 years
Secondary outcomes (3)
Number of reported all cause mortality
Measured: 1 year
Number of reported all cause mortality
Measured: 5 years
Number of reported all cause mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Mar 2022
- Primary completion5 Jan 2024
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Durukan, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285280
- Sponsor's protocol ID
- EDcard
- Status last verified
- Jan 2024
- First submitted
- 2 Feb 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durukan E, Jensen CFS, Dons M, Sengelov M, Landler NE, Skaarup KG, Hojbjerg Lassen MC, Johansen ND, Ostergren PB, Sonksen J, Biering-Sorensen T, Fode M. Risk factors associated with cardiac dysfunction in men with erectile dysfunction. J Sex Med. 2026 Mar 9;23(4):qdag074. doi: 10.1093/jsxmed/qdag074.
PubMed 41843808
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors Associated With Cardiovascular Comorbidity in Men With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05285280
- Acronym / sponsor ID
- EDcard
- Keywords
- Echocardiography, 3D Echocardiography, Strain Rate Imaging, Tissue Doppler, Speckle Tracking
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be invited from the Urology outpatient clinic at Gentofte Hospital.
Key inclusion criteria (1 listed)
- Men above 40 years old diagnosed with ED will be eligible to participate if none of the exclusion criteria below are present.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyThe 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. | Diagnostic test | – |
Primary outcome
Number of reported cardiac arrest through medical records
Time frame: 1 year
Number of reported cardiac arrest through medical records
Time frame: 5 years
Number of reported cardiac arrest through medical records
Time frame: 10 years
Number of reported hospital admission with heart failure through medical records
Time frame: 1 year
Number of reported hospital admission with heart failure through medical records
Time frame: 5 years
Number of reported hospital admission with heart failure through medical records
Time frame: 10 years
Number of reported peripheral artery disease through medical records
Time frame: 1 year
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Number of reported peripheral artery disease through medical records
Time frame: 5 years
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Number of reported peripheral artery disease through medical records
Time frame: 10 years
Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).
Number of reported coronary heart disease through medical records
Time frame: 1 year
Registration of: Coronary angiography
Number of reported coronary heart disease through medical records
Time frame: 5 years
Registration of: Coronary angiography
Number of reported coronary heart disease through medical records
Time frame: 10 years
Registration of: Coronary angiography
Number of reported hospital admission with acute myocardial infarction through medical records
Time frame: 1 year
Number of reported hospital admission with acute myocardial infarction through medical records
Time frame: 5 years
Number of reported hospital admission with acute myocardial infarction through medical records
Time frame: 10 years
Number of reported angina pectoris through medical records
Time frame: 1 year
Number of reported angina pectoris through medical records
Time frame: 5 years
Number of reported angina pectoris through medical records
Time frame: 10 years
Number of reported ischemic heart disease through medical records
Time frame: 1 year
Number of reported ischemic heart disease through medical records
Time frame: 5 years
Number of reported ischemic heart disease through medical records
Time frame: 10 years
3 secondary outcomes
Number of reported all cause mortality
Time frame: 1 year
Number of reported all cause mortality
Time frame: 5 years
Number of reported all cause mortality
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 41843808Durukan E, Jensen CFS, Dons M, Sengelov M, Landler NE, Skaarup KG, Hojbjerg Lassen MC, Johansen ND, Ostergren PB, Sonksen J, Biering-Sorensen T, Fode M. Risk factors associated with cardiac dysfunction in men with erectile dysfunction. J Sex Med. 2026 Mar 9;23(4):qdag074. doi: 10.1093/jsxmed/qdag074.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction and Cardiovascular Diseases, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of reported cardiac arrest through medical records (time frame: 1 year). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.