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NCT Number: NCT07719790

Does Erectile Dysfonction Allow to Evaluate 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hôpital Lariboisière

Paris, France, 75010

Location contact

Guy AMAH, MD

CONTACT

[email protected]

0149958088 ext. +33

Guy AMAH, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Subendocardial viability ratio (SEVR)

    Time frame: 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.

Secondary outcomes

  1. Carotid-femoral pulse wave velocity

    Time frame: 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.

  2. Central pulsed pressure

    Time frame: Once, during the day-hospital visit

    Central pulse pressure (mmHg) derived noninvasively from the central aortic pressure waveform obtained by radial artery applanation tonometry.

  3. Pulse pressure amplification

    Time frame: Once, during the day-hospital visit

    Defined as the ratio of peripheral radial pulse pressure to central aortic pulse pressure.

  4. Augmentation index

    Time frame: Once, during the day-hospital visit

    Augmentation index (%), calculated as augmentation pressure divided by central aortic pulse pressure and measured by applanation tonometry.

  5. Maximum exercise capacity

    Time frame: 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.

  6. Left ventricular mass index

    Time frame: Once, during the day-hospital visit

    Left ventricular mass indexed to body surface area (g/m²), measured by echocardiography.

  7. Coronary calcium score

    Time frame: Once, during the day-hospital visit

    Agatston coronary artery calcium score obtained from non-contrast cardiac computed tomography.

  8. High-sensitivity C-reactive protein

    Time frame: Once, during the day-hospital visit

    Plasma high-sensitivity C-reactive protein concentration measured from a venous blood sample.

  9. SCORE2 and SCORE2-OP

    Time frame: 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.

    • Low to moderate risk: <5%
    • High risk: 5-9%
    • Very high risk: ≥10%

  10. SF-12 quality-of-life scores

    Time frame: 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.

    • Score <40: significantly reduced quality of life
    • 40-50: moderately affected quality of life
    • ≥50: normal quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Guy AMAH, MD

CONTACT

[email protected]

0149958088 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Does Erectile Dysfonction is Correlated to Subendocardial Viability Among Treated Patients With Hypertension ?

Acronym: DEVISE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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