About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Permanent atrial fibrillation
Recurrent cardiac arrhythmias
Not affiliated with a French social security scheme
Opposition to participation
Trial 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.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Central pulsed pressure
Central pulse pressure (mmHg) derived noninvasively from the central aortic pressure waveform obtained by radial artery applanation tonometry.
Pulse pressure amplification
Defined as the ratio of peripheral radial pulse pressure to central aortic pulse pressure.
Augmentation index
Augmentation index (%), calculated as augmentation pressure divided by central aortic pulse pressure and measured by applanation tonometry.
Sponsors and contacts
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