Does Erectile Dysfonction Allow to Evaluate Subendocardial Viability Among Treated Patients With Hypertension ?

NCT07719790 | Not Yet Recruiting

• 2 other identifiers: APHP251912IDRCB : 2026-A00520-51
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Erectile Dysfunction; Hypertension

Keywords

erectile dysfunction; subendocardial viability; hypertension; Arterial stiffness

Outcome Measures

Primary Outcomes (1)

• 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.

  Once, during the day-hospital visit

Secondary Outcomes (10)

• Carotid-femoral pulse wave velocity

  Once, during the day-hospital visit

• Central pulsed pressure

  Once, during the day-hospital visit

• Pulse pressure amplification

  Once, during the day-hospital visit

• Augmentation index

  Once, during the day-hospital visit

• Maximum exercise capacity

  Once, during the day-hospital visit

Study Arms (2)

Treated hypertensive men with erectile dysfunction

Treated hypertensive men without erectile dysfunction

Patients with hypertension without erectile dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Permanent atrial fibrillation
• Recurrent cardiac arrhythmias
• Not affiliated with a French social security scheme
• Opposition to participation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Lariboisière

Paris, France, 75010, France

Location

Related Publications (24)

• 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.

  PMID: 21228823 BACKGROUND

• Jackson 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.

  PMID: 23714173 BACKGROUND

• Rosen 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.

  PMID: 10637462 BACKGROUND

• Chiurlia 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.

  PMID: 16226175 BACKGROUND

• Montorsi 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.

  PMID: 16387561 BACKGROUND

• Vlachopoulos 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.

  PMID: 25412676 BACKGROUND

• Montorsi 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.

  PMID: 16901623 BACKGROUND

• Nehra 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.

  PMID: 22862865 BACKGROUND

• Montorsi 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.

  PMID: 25337840 BACKGROUND

• Jackson 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.

  PMID: 20584218 BACKGROUND

• Vlachopoulos 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.

  PMID: 23616415 BACKGROUND

• Vlachopoulos 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.

  PMID: 23300267 BACKGROUND

• Dong 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.

  PMID: 21920268 BACKGROUND

• Banks 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.

  PMID: 23382654 BACKGROUND

• Thompson 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.

  PMID: 16414947 BACKGROUND

• Schouten BW, Bohnen AM, Bosch JL, Bernsen RM, Deckers JW, Dohle GR, Thomas S. Erectile dysfunction prospectively associated with cardiovascular disease in the Dutch general population: results from the Krimpen Study. Int J Impot Res. 2008 Jan-Feb;20(1):92-9. doi: 10.1038/sj.ijir.3901604. Epub 2007 Aug 30.

  PMID: 17728804 BACKGROUND

• Araujo AB, Travison TG, Ganz P, Chiu GR, Kupelian V, Rosen RC, Hall SA, McKinlay JB. Erectile dysfunction and mortality. J Sex Med. 2009 Sep;6(9):2445-54. doi: 10.1111/j.1743-6109.2009.01354.x. Epub 2009 Jun 15.

  PMID: 19538544 BACKGROUND

• Greenstein A, Chen J, Miller H, Matzkin H, Villa Y, Braf Z. Does severity of ischemic coronary disease correlate with erectile function? Int J Impot Res. 1997 Sep;9(3):123-6. doi: 10.1038/sj.ijir.3900282.

  PMID: 9315488 BACKGROUND

• Kumagai H, Yoshikawa T, Myoenzono K, Kosaki K, Akazawa N, Asako ZM, Tsujimoto T, Kidokoro T, Tanaka K, Maeda S. Sexual Function Is an Indicator of Central Arterial Stiffness and Arterial Stiffness Gradient in Japanese Adult Men. J Am Heart Assoc. 2018 May 5;7(10):e007964. doi: 10.1161/JAHA.117.007964.

  PMID: 29730645 BACKGROUND

• Peyton CC, Colaco MA, Kovell RC, Kim JH, Terlecki RP. Erectile Dysfunction is Predictive of Endothelial Dysfunction in a Well Visit Population. J Urol. 2016 Apr;195(4 Pt 1):1045-50. doi: 10.1016/j.juro.2015.11.037. Epub 2015 Nov 22.

  PMID: 26614890 BACKGROUND

• Gazzaruso C, Giordanetti S, De Amici E, Bertone G, Falcone C, Geroldi D, Fratino P, Solerte SB, Garzaniti A. Relationship between erectile dysfunction and silent myocardial ischemia in apparently uncomplicated type 2 diabetic patients. Circulation. 2004 Jul 6;110(1):22-6. doi: 10.1161/01.CIR.0000133278.81226.C9. Epub 2004 Jun 21.

  PMID: 15210604 BACKGROUND

• Sullivan ME, Keoghane SR, Miller MA. Vascular risk factors and erectile dysfunction. BJU Int. 2001 Jun;87(9):838-45. doi: 10.1046/j.1464-410x.2001.02211.x. No abstract available.

  PMID: 11412223 BACKGROUND

• Manolis A, Doumas M. Sexual dysfunction: the 'prima ballerina' of hypertension-related quality-of-life complications. J Hypertens. 2008 Nov;26(11):2074-84. doi: 10.1097/HJH.0b013e32830dd0c6.

  PMID: 18854743 BACKGROUND

• Ayta IA, McKinlay JB, Krane RJ. The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int. 1999 Jul;84(1):50-6. doi: 10.1046/j.1464-410x.1999.00142.x.

  PMID: 10444124 BACKGROUND

MeSH Terms

Conditions

Hypertension; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Guy AMAH, MD

CONTACT

0149958088; guy.amah@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 22, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): January 17, 2028
• Study Completion (Estimated): January 17, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

FR (1)