HypertensionDEVISENCT07719790
Does Erectile Dysfonction Allow to Evaluate Subendocardial Viability Among Treated Patients With Hypertension ?
An observational study of Hypertension and Erectile Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Erectile dysfunction (ED) is associated with subclinical atherosclerosis and may precede clinically apparent coronary artery disease by two to five years. It may therefore serve as an early warning sign of cardiovascular disease and help identify patients who could benefit from intensified cardiovascular risk-factor… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypertension, Erectile Dysfunction
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2026to 17 Jan 2028
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult men with pharmacologically treated hypertension who are consecutively admitted to the Clinical Physiology and Functional Testing Unit at Lariboisière Hospital for day-hospital assessment of hypertension-mediated organ damage. Participants must have no history of cardiovascular disease, particularly coronary artery disease, and must be asymptomatic for coronary disease.
Who may be able to join
- Male participant aged 18 years or older.
- Confirmed diagnosis of hypertension.
- Receiving pharmacological antihypertensive treatment.
- Consecutively admitted to the hypertension day-hospital unit for assessment of hypertension-mediated organ damage.
- No history of cardiovascular disease, particularly coronary artery disease, and asymptomatic for coronary artery disease.
- Affiliated with a French social security scheme.
- Having received the study information and not expressed opposition to participating.
Who cannot join
- Permanent atrial fibrillation
- Recurrent cardiac arrhythmias
- Not affiliated with a French social security scheme
- Opposition to participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Lariboisière
Paris, France, 75010
Guy AMAH, MD, 0149958088 ext. +33, guy.amah@aphp.fr
Guy AMAH, MD
About this study
Official title: Does Erectile Dysfonction is Correlated to Subendocardial Viability Among Treated Patients With Hypertension ?
Erectile dysfunction (ED) is associated with subclinical atherosclerosis and may precede clinically apparent coronary artery disease by two to five years. It may therefore serve as an early warning sign of cardiovascular disease and help identify patients who could benefit from intensified cardiovascular risk-factor management. The subendocardial viability ratio (SEVR), also known as the Buckberg index, is obtained noninvasively from radial artery applanation tonometry. SEVR reflects the balance between myocardial oxygen supply and demand and has been associated with coronary flow reserve in patients with hypertension. The DEVISE study will compare SEVR between treated men with hypertension who have ED with those who do not. The study will also examine the associations between ED severity and arterial stiffness, central hemodynamics, exercise capacity, left ventricular mass, coronary artery calcium, high-sensitivity C-reactive protein, cardiovascular risk, and quality of life.
The question addressed in our study is whether an alteration in subendocardial viability represents subclinical coronary disease associated with ED.
Read the detailed description
DEVISE is a monocenter, prospective, noninterventional, cross-sectional, observational study. Consecutive adult men receiving pharmacological treatment for hypertension who are admitted to the hypertension day hospital unit at Lariboisière Hospital for assessment of hypertension-mediated organ damage will be screened.
Participants will complete the five-item International Index of Erectile Function (IIEF-5) questionnaire. Participants will be classified into two groups according to the presence or absence of ED. ED is defined as an IIEF-5 score of 21 or lower and will be further categorized as mild (17-21), mild-to-moderate (12-16), moderate (8-11), or severe (5-7).
All cardiovascular examinations are performed as part of routine care except for the completion of the IIEF-5 and SF-12 questionnaires. Radial artery applanation tonometry will be used to derive the central aortic pressure waveform and calculate systolic arterial velocity reserve (SEVR), central pulse pressure, pulse pressure amplification, and the augmentation index. Carotid-femoral pulse wave velocity will be measured as an index of aortic stiffness. Other assessments will include a bicycle exercise test, echocardiography, noncontrast computed tomography for coronary artery calcium scoring, and blood testing, including high-sensitivity C-reactive protein. Additionally, SCORE2 or SCORE2-OP calculations will be performed, and the SF-12 quality-of-life questionnaire will be administered.
The study will include a total of 120 participants, with recruitment ending once 60 participants have been enrolled in each group. Each participant will be observed for one day, corresponding to the day-hospital visit. The planned recruitment period is 18 months.
- Conditions
- Hypertension, Erectile Dysfunction
- Keywords
- erectile dysfunction, subendocardial viability, hypertension, Arterial stiffness
- Medical subject headings
- Hypertension, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treated hypertensive men with erectile dysfunction | Treated hypertensive men without erectile dysfunction | |
| Patients with hypertension without erectile dysfunction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subendocardial viability ratio (SEVR)
SEVR, expressed as a percentage, calculated from the central aortic pressure waveform obtained by radial artery applanation tonometry. SEVR is calculated as 100 × diastolic pressure-time integral / systolic pressure-time integral. The value will be compared between participants with and without erectile dysfunction.
Measured: Once, during the day-hospital visit
Secondary outcomes (10)
Carotid-femoral pulse wave velocity
Aortic stiffness measured as carotid-femoral pulse wave velocity (m/s) using applanation tonometry. A value of 10 m/s or greater is considered increased.
Measured: Once, during the day-hospital visit
Central pulsed pressure
Central pulse pressure (mmHg) derived noninvasively from the central aortic pressure waveform obtained by radial artery applanation tonometry.
Measured: Once, during the day-hospital visit
Pulse pressure amplification
Defined as the ratio of peripheral radial pulse pressure to central aortic pulse pressure.
Measured: Once, during the day-hospital visit
Augmentation index
Augmentation index (%), calculated as augmentation pressure divided by central aortic pulse pressure and measured by applanation tonometry.
Measured: Once, during the day-hospital visit
Maximum exercise capacity
Expressed in METs (Equivalent Metabolic of the Task) (1 MET = 3,5 mL of O2 per kilogram per minute [mL / kg / min]). The Maximum capacity reached during exercise is determined during a symptom-limited bicycle ergometer test. The protocol starts at 60 watts for 2 minutes, followed by 30-W increments every 2 minutes until exhaustion or limiting symptoms.
Measured: Once, during the day-hospital visit
Left ventricular mass index
Left ventricular mass indexed to body surface area (g/m²), measured by echocardiography.
Measured: Once, during the day-hospital visit
Coronary calcium score
Agatston coronary artery calcium score obtained from non-contrast cardiac computed tomography.
Measured: Once, during the day-hospital visit
High-sensitivity C-reactive protein
Plasma high-sensitivity C-reactive protein concentration measured from a venous blood sample.
Measured: Once, during the day-hospital visit
SCORE2 and SCORE2-OP
Estimated 10-year risk (%) of fatal and nonfatal cardiovascular events, calculated using SCORE2 for participants aged 40-69 years and SCORE2-OP for participants aged 70 years or older.
- Low to moderate risk: <5%
- High risk: 5-9%
- Very high risk: ≥10%
Measured: Once, during the day-hospital visit
SF-12 quality-of-life scores
Physical Component Summary and Mental Component Summary scores derived from the 12-item Short Form Health Survey (SF-12). Both component scores are standardized to a population mean of 50 with a standard deviation of 10.
- Score <40: significantly reduced quality of life
- 40-50: moderately affected quality of life
- ≥50: normal quality of life
Measured: Once, during the day-hospital visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start17 Jul 2026 (estimated)
- Primary completion17 Jan 2028 (estimated)
- Study completion17 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719790
- Sponsor's protocol ID
- APHP251912
- Other IDs
- IDRCB : 2026-A00520-51
- Acronym
- DEVISE
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsiachris D, Tsioufis C, Syrseloudis D, Roussos D, Tatsis I, Dimitriadis K, Toutouzas K, Tsiamis E, Stefanadis C. Subendocardial viability ratio as an index of impaired coronary flow reserve in hypertensives without significant coronary artery stenoses. J Hum Hypertens. 2012 Jan;26(1):64-70. doi: 10.1038/jhh.2010.127. Epub 2011 Jan 13.
PubMed 21228823Jackson G, Nehra A, Miner M, Billups KL, Burnett AL, Buvat J, Carson CC, Cunningham G, Goldstein I, Guay AT, Hackett G, Kloner RA, Kostis JB, Montorsi P, Ramsey M, Rosen R, Sadovsky R, Seftel AD, Shabsigh R, Vlachopoulos C, Wu FC. The assessment of vascular risk in men with erectile dysfunction: the role of the cardiologist and general physician. Int J Clin Pract. 2013 Nov;67(11):1163-72. doi: 10.1111/ijcp.12200. Epub 2013 May 28.
PubMed 23714173Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
PubMed 10637462Chiurlia E, D'Amico R, Ratti C, Granata AR, Romagnoli R, Modena MG. Subclinical coronary artery atherosclerosis in patients with erectile dysfunction. J Am Coll Cardiol. 2005 Oct 18;46(8):1503-6. doi: 10.1016/j.jacc.2005.06.068. Epub 2005 Sep 28.
PubMed 16226175Montorsi P, Ravagnani PM, Galli S, Rotatori F, Briganti A, Salonia A, Rigatti P, Montorsi F. The artery size hypothesis: a macrovascular link between erectile dysfunction and coronary artery disease. Am J Cardiol. 2005 Dec 26;96(12B):19M-23M. doi: 10.1016/j.amjcard.2005.07.006. Epub 2005 Nov 4.
PubMed 16387561Vlachopoulos C, Ioakeimidis N, Stefanadis C. Biomarkers, erectile dysfunction, and cardiovascular risk prediction: the latest of an evolving concept. Asian J Androl. 2015 Jan-Feb;17(1):17-20. doi: 10.4103/1008-682X.143250.
PubMed 25412676Montorsi P, Ravagnani PM, Galli S, Salonia A, Briganti A, Werba JP, Montorsi F. Association between erectile dysfunction and coronary artery disease: Matching the right target with the right test in the right patient. Eur Urol. 2006 Oct;50(4):721-31. doi: 10.1016/j.eururo.2006.07.015. Epub 2006 Jul 28.
PubMed 16901623Nehra A, Jackson G, Miner M, Billups KL, Burnett AL, Buvat J, Carson CC, Cunningham GR, Ganz P, Goldstein I, Guay AT, Hackett G, Kloner RA, Kostis J, Montorsi P, Ramsey M, Rosen R, Sadovsky R, Seftel AD, Shabsigh R, Vlachopoulos C, Wu FC. The Princeton III Consensus recommendations for the management of erectile dysfunction and cardiovascular disease. Mayo Clin Proc. 2012 Aug;87(8):766-78. doi: 10.1016/j.mayocp.2012.06.015.
PubMed 22862865Montorsi P, Ravagnani PM, Vlachopoulos C. Clinical significance of erectile dysfunction developing after acute coronary event: exception to the rule or confirmation of the artery size hypothesis? Asian J Androl. 2015 Jan-Feb;17(1):21-5. doi: 10.4103/1008-682X.139254.
PubMed 25337840Jackson G, Boon N, Eardley I, Kirby M, Dean J, Hackett G, Montorsi P, Montorsi F, Vlachopoulos C, Kloner R, Sharlip I, Miner M. Erectile dysfunction and coronary artery disease prediction: evidence-based guidance and consensus. Int J Clin Pract. 2010 Jun;64(7):848-57. doi: 10.1111/j.1742-1241.2010.02410.x.
PubMed 20584218Vlachopoulos C, Jackson G, Stefanadis C, Montorsi P. Erectile dysfunction in the cardiovascular patient. Eur Heart J. 2013 Jul;34(27):2034-46. doi: 10.1093/eurheartj/eht112. Epub 2013 Apr 24.
PubMed 23616415Vlachopoulos CV, Terentes-Printzios DG, Ioakeimidis NK, Aznaouridis KA, Stefanadis CI. Prediction of cardiovascular events and all-cause mortality with erectile dysfunction: a systematic review and meta-analysis of cohort studies. Circ Cardiovasc Qual Outcomes. 2013 Jan 1;6(1):99-109. doi: 10.1161/CIRCOUTCOMES.112.966903. Epub 2013 Jan 8.
PubMed 23300267Dong JY, Zhang YH, Qin LQ. Erectile dysfunction and risk of cardiovascular disease: meta-analysis of prospective cohort studies. J Am Coll Cardiol. 2011 Sep 20;58(13):1378-85. doi: 10.1016/j.jacc.2011.06.024.
PubMed 21920268Banks E, Joshy G, Abhayaratna WP, Kritharides L, Macdonald PS, Korda RJ, Chalmers JP. Erectile dysfunction severity as a risk marker for cardiovascular disease hospitalisation and all-cause mortality: a prospective cohort study. PLoS Med. 2013;10(1):e1001372. doi: 10.1371/journal.pmed.1001372. Epub 2013 Jan 29.
PubMed 23382654Thompson IM, Tangen CM, Goodman PJ, Probstfield JL, Moinpour CM, Coltman CA. Erectile dysfunction and subsequent cardiovascular disease. JAMA. 2005 Dec 21;294(23):2996-3002. doi: 10.1001/jama.294.23.2996.
PubMed 16414947
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Erectile Dysfonction is Correlated to Subendocardial Viability Among Treated Patients With Hypertension ?
- ClinicalTrials.gov ID
- NCT07719790
- Acronym / sponsor ID
- DEVISE / APHP251912
- Conditions
- Hypertension, Erectile Dysfunction
- Keywords
- erectile dysfunction, subendocardial viability, hypertension, Arterial stiffness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Jul 2026 (estimated)
- Primary completion
- 17 Jan 2028 (estimated)
- Study completion
- 17 Jan 2028 (estimated)
- First posted
- 22 Jul 2026 (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.
Erectile dysfunction (ED) is associated with subclinical atherosclerosis and may precede clinically apparent coronary artery disease by two to five years. It may therefore serve as an early warning sign of cardiovascular disease and help identify patients who could benefit from intensified cardiovascular risk-factor management. The subendocardial viability ratio (SEVR), also known as the Buckberg index, is obtained noninvasively from radial artery applanation tonometry. SEVR reflects the balance between myocardial oxygen supply and demand and has been associated with coronary flow reserve in patients with hypertension. The DEVISE study will compare SEVR between treated men with hypertension who have ED with those who do not. The study will also examine the associations between ED severity and arterial stiffness, central hemodynamics, exercise capacity, left ventricular mass, coronary artery calcium, high-sensitivity C-reactive protein, cardiovascular risk, and quality of life.
The question addressed in our study is whether an alteration in subendocardial viability represents subclinical coronary disease associated with ED.
Detailed description
DEVISE is a monocenter, prospective, noninterventional, cross-sectional, observational study. Consecutive adult men receiving pharmacological treatment for hypertension who are admitted to the hypertension day hospital unit at Lariboisière Hospital for assessment of hypertension-mediated organ damage will be screened.
Participants will complete the five-item International Index of Erectile Function (IIEF-5) questionnaire. Participants will be classified into two groups according to the presence or absence of ED. ED is defined as an IIEF-5 score of 21 or lower and will be further categorized as mild (17-21), mild-to-moderate (12-16), moderate (8-11), or severe (5-7).
All cardiovascular examinations are performed as part of routine care except for the completion of the IIEF-5 and SF-12 questionnaires. Radial artery applanation tonometry will be used to derive the central aortic pressure waveform and calculate systolic arterial velocity reserve (SEVR), central pulse pressure, pulse pressure amplification, and the augmentation index. Carotid-femoral pulse wave velocity will be measured as an index of aortic stiffness. Other assessments will include a bicycle exercise test, echocardiography, noncontrast computed tomography for coronary artery calcium scoring, and blood testing, including high-sensitivity C-reactive protein. Additionally, SCORE2 or SCORE2-OP calculations will be performed, and the SF-12 quality-of-life questionnaire will be administered.
The study will include a total of 120 participants, with recruitment ending once 60 participants have been enrolled in each group. Each participant will be observed for one day, corresponding to the day-hospital visit. The planned recruitment period is 18 months.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated hypertensive men with erectile dysfunction | – | –Treated hypertensive men without erectile dysfunction |
| Patients with hypertension without erectile dysfunction | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men with pharmacologically treated hypertension who are consecutively admitted to the Clinical Physiology and Functional Testing Unit at Lariboisière Hospital for day-hospital assessment of hypertension-mediated organ damage. Participants must have no history of cardiovascular disease, particularly coronary artery disease, and must be asymptomatic for coronary disease.
Key inclusion criteria (7 listed)
- Male participant aged 18 years or older.
- Confirmed diagnosis of hypertension.
- Receiving pharmacological antihypertensive treatment.
- Consecutively admitted to the hypertension day-hospital unit for assessment of hypertension-mediated organ damage.
- No history of cardiovascular disease, particularly coronary artery disease, and asymptomatic for coronary artery disease.
Key exclusion criteria (4 listed)
- Permanent atrial fibrillation
- Recurrent cardiac arrhythmias
- Not affiliated with a French social security scheme
- Opposition to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subendocardial viability ratio (SEVR)
Time frame: Once, during the day-hospital visit
SEVR, expressed as a percentage, calculated from the central aortic pressure waveform obtained by radial artery applanation tonometry. SEVR is calculated as 100 × diastolic pressure-time integral / systolic pressure-time integral. The value will be compared between participants with and without erectile dysfunction.
10 secondary outcomes
Carotid-femoral pulse wave velocity
Time frame: Once, during the day-hospital visit
Central pulsed pressure
Time frame: Once, during the day-hospital visit
Pulse pressure amplification
Time frame: Once, during the day-hospital visit
Augmentation index
Time frame: Once, during the day-hospital visit
Maximum exercise capacity
Time frame: Once, during the day-hospital visit
Left ventricular mass index
Time frame: Once, during the day-hospital visit
Coronary calcium score
Time frame: Once, during the day-hospital visit
High-sensitivity C-reactive protein
Time frame: Once, during the day-hospital visit
SCORE2 and SCORE2-OP
Time frame: Once, during the day-hospital visit
SF-12 quality-of-life scores
Time frame: Once, during the day-hospital visit
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 22 Jul 2026.
- Background: PubMed 21228823Tsiachris D, Tsioufis C, Syrseloudis D, Roussos D, Tatsis I, Dimitriadis K, Toutouzas K, Tsiamis E, Stefanadis C. Subendocardial viability ratio as an index of impaired coronary flow reserve in hypertensives without significant coronary artery stenoses. J Hum Hypertens. 2012 Jan;26(1):64-70. doi: 10.1038/jhh.2010.127. Epub 2011 Jan 13.
- Background: PubMed 23714173Jackson G, Nehra A, Miner M, Billups KL, Burnett AL, Buvat J, Carson CC, Cunningham G, Goldstein I, Guay AT, Hackett G, Kloner RA, Kostis JB, Montorsi P, Ramsey M, Rosen R, Sadovsky R, Seftel AD, Shabsigh R, Vlachopoulos C, Wu FC. The assessment of vascular risk in men with erectile dysfunction: the role of the cardiologist and general physician. Int J Clin Pract. 2013 Nov;67(11):1163-72. doi: 10.1111/ijcp.12200. Epub 2013 May 28.
- Background: PubMed 10637462Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
- Background: PubMed 16226175Chiurlia E, D'Amico R, Ratti C, Granata AR, Romagnoli R, Modena MG. Subclinical coronary artery atherosclerosis in patients with erectile dysfunction. J Am Coll Cardiol. 2005 Oct 18;46(8):1503-6. doi: 10.1016/j.jacc.2005.06.068. Epub 2005 Sep 28.
- Background: PubMed 16387561Montorsi P, Ravagnani PM, Galli S, Rotatori F, Briganti A, Salonia A, Rigatti P, Montorsi F. The artery size hypothesis: a macrovascular link between erectile dysfunction and coronary artery disease. Am J Cardiol. 2005 Dec 26;96(12B):19M-23M. doi: 10.1016/j.amjcard.2005.07.006. Epub 2005 Nov 4.
- Background: PubMed 25412676Vlachopoulos C, Ioakeimidis N, Stefanadis C. Biomarkers, erectile dysfunction, and cardiovascular risk prediction: the latest of an evolving concept. Asian J Androl. 2015 Jan-Feb;17(1):17-20. doi: 10.4103/1008-682X.143250.
- Background: PubMed 16901623Montorsi P, Ravagnani PM, Galli S, Salonia A, Briganti A, Werba JP, Montorsi F. Association between erectile dysfunction and coronary artery disease: Matching the right target with the right test in the right patient. Eur Urol. 2006 Oct;50(4):721-31. doi: 10.1016/j.eururo.2006.07.015. Epub 2006 Jul 28.
- Background: PubMed 22862865Nehra A, Jackson G, Miner M, Billups KL, Burnett AL, Buvat J, Carson CC, Cunningham GR, Ganz P, Goldstein I, Guay AT, Hackett G, Kloner RA, Kostis J, Montorsi P, Ramsey M, Rosen R, Sadovsky R, Seftel AD, Shabsigh R, Vlachopoulos C, Wu FC. The Princeton III Consensus recommendations for the management of erectile dysfunction and cardiovascular disease. Mayo Clin Proc. 2012 Aug;87(8):766-78. doi: 10.1016/j.mayocp.2012.06.015.
- Background: PubMed 25337840Montorsi P, Ravagnani PM, Vlachopoulos C. Clinical significance of erectile dysfunction developing after acute coronary event: exception to the rule or confirmation of the artery size hypothesis? Asian J Androl. 2015 Jan-Feb;17(1):21-5. doi: 10.4103/1008-682X.139254.
- Background: PubMed 20584218Jackson G, Boon N, Eardley I, Kirby M, Dean J, Hackett G, Montorsi P, Montorsi F, Vlachopoulos C, Kloner R, Sharlip I, Miner M. Erectile dysfunction and coronary artery disease prediction: evidence-based guidance and consensus. Int J Clin Pract. 2010 Jun;64(7):848-57. doi: 10.1111/j.1742-1241.2010.02410.x.
- Background: PubMed 23616415Vlachopoulos C, Jackson G, Stefanadis C, Montorsi P. Erectile dysfunction in the cardiovascular patient. Eur Heart J. 2013 Jul;34(27):2034-46. doi: 10.1093/eurheartj/eht112. Epub 2013 Apr 24.
- Background: PubMed 23300267Vlachopoulos CV, Terentes-Printzios DG, Ioakeimidis NK, Aznaouridis KA, Stefanadis CI. Prediction of cardiovascular events and all-cause mortality with erectile dysfunction: a systematic review and meta-analysis of cohort studies. Circ Cardiovasc Qual Outcomes. 2013 Jan 1;6(1):99-109. doi: 10.1161/CIRCOUTCOMES.112.966903. Epub 2013 Jan 8.
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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.
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 Hypertension and Erectile Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 22 Jul 2026. 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 France. 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?
Contact Guy AMAH, MD (0149958088 ext. +33, guy.amah@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subendocardial viability ratio (SEVR) (time frame: Once, during the day-hospital visit). 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 NCT07719790, which also lists 24 linked publications.
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 22 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.