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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Treated hypertensive men with erectile dysfunction
Group B: Patients with hypertension without erectile dysfunction

Trial outcomes

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.

Time frame
Once, during the day-hospital visit

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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