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

17 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

120

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
    • France
      • Paris, France, Frankrijk, 75010
        • Hôpital Lariboisière
        • Contact:
        • Hoofdonderzoeker:
          • Guy AMAH, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Subendocardial viability ratio (SEVR)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Carotid-femoral pulse wave velocity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

17 juli 2026

Primaire voltooiing (Geschat)

17 januari 2028

Studie voltooiing (Geschat)

17 januari 2028

Studieregistratiedata

Eerst ingediend

3 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2026

Eerst geplaatst (Werkelijk)

22 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • APHP251912
  • IDRCB : 2026-A00520-51 (Andere identificatie: ANSM)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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