Does Erectile Dysfonction Allow to Evaluate Subendocardial Viability Among Treated Patients With Hypertension ? (DEVISE)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Guy AMAH, MD
- 电话号码：+33 0149958088
- 邮箱：guy.amah@aphp.fr
学习地点
-
-
France
-
Paris、France、法国、75010
- Hôpital Lariboisière
-
接触：
- Guy AMAH, MD
- 电话号码：+33 0149958088
- 邮箱：guy.amah@aphp.fr
-
首席研究员：
- Guy AMAH, MD
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Permanent atrial fibrillation
- Recurrent cardiac arrhythmias
- Not affiliated with a French social security scheme
- Opposition to participation
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Treated hypertensive men with erectile dysfunction
Treated hypertensive men without erectile dysfunction
|
|
Patients with hypertension without erectile dysfunction
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subendocardial viability ratio (SEVR)
大体时间：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.
|
Once, during the day-hospital visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Carotid-femoral pulse wave velocity
大体时间：Once, during the day-hospital visit
|
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.
|
Once, during the day-hospital visit
|
|
Central pulsed pressure
大体时间：Once, during the day-hospital visit
|
Central pulse pressure (mmHg) derived noninvasively from the central aortic pressure waveform obtained by radial artery applanation tonometry.
|
Once, during the day-hospital visit
|
|
Pulse pressure amplification
大体时间：Once, during the day-hospital visit
|
Defined as the ratio of peripheral radial pulse pressure to central aortic pulse pressure.
|
Once, during the day-hospital visit
|
|
Augmentation index
大体时间：Once, during the day-hospital visit
|
Augmentation index (%), calculated as augmentation pressure divided by central aortic pulse pressure and measured by applanation tonometry.
|
Once, during the day-hospital visit
|
|
Maximum exercise capacity
大体时间：Once, during the day-hospital visit
|
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.
|
Once, during the day-hospital visit
|
|
Left ventricular mass index
大体时间：Once, during the day-hospital visit
|
Left ventricular mass indexed to body surface area (g/m²), measured by echocardiography.
|
Once, during the day-hospital visit
|
|
Coronary calcium score
大体时间：Once, during the day-hospital visit
|
Agatston coronary artery calcium score obtained from non-contrast cardiac computed tomography.
|
Once, during the day-hospital visit
|
|
High-sensitivity C-reactive protein
大体时间：Once, during the day-hospital visit
|
Plasma high-sensitivity C-reactive protein concentration measured from a venous blood sample.
|
Once, during the day-hospital visit
|
|
SCORE2 and SCORE2-OP
大体时间：Once, during the day-hospital visit
|
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.
|
Once, during the day-hospital visit
|
|
SF-12 quality-of-life scores
大体时间：Once, during the day-hospital visit
|
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.
|
Once, during the day-hospital visit
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.