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

July 17, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • France
      • Paris, France, France, 75010
        • Hôpital Lariboisière
        • Contact:
        • Principal Investigator:
          • Guy AMAH, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Treated hypertensive men with erectile dysfunction
Treated hypertensive men without erectile dysfunction
Patients with hypertension without erectile dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once, during the day-hospital visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once, during the day-hospital visit
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.
Once, during the day-hospital visit
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.
Once, during the day-hospital visit
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.
Once, during the day-hospital visit
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.
Once, during the day-hospital visit
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.
Once, during the day-hospital visit
Coronary calcium score
Time Frame: 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
Time Frame: 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
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%
Once, during the day-hospital visit
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
Once, during the day-hospital visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 17, 2026

Primary Completion (Estimated)

January 17, 2028

Study Completion (Estimated)

January 17, 2028

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP251912
  • IDRCB : 2026-A00520-51 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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