An observational study in Hypertension and Erectile Dysfunction, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 120 is below the median of 350 across 1,163 observational studies indexed under Hypertension.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Treated hypertensive men without erectile dysfunction
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.
Time frame: Once, during the day-hospital visit
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.
Time frame: 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.
Time frame: Once, during the day-hospital visit
Pulse pressure amplification
Defined as the ratio of peripheral radial pulse pressure to central aortic pulse pressure.
Time frame: 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.
Time frame: 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.
Time frame: Once, during the day-hospital visit
Left ventricular mass index
Left ventricular mass indexed to body surface area (g/m²), measured by echocardiography.
Time frame: Once, during the day-hospital visit
Coronary calcium score
Agatston coronary artery calcium score obtained from non-contrast cardiac computed tomography.
Time frame: Once, during the day-hospital visit
High-sensitivity C-reactive protein
Plasma high-sensitivity C-reactive protein concentration measured from a venous blood sample.
Time frame: 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%
Time frame: 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
Time frame: Once, during the day-hospital visit
Start is estimated for Jul 2026; primary completion for Jan 2028, 18 months later.
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