Does Erectile Dysfonction Allow to Evaluate Subendocardial Viability Among Treated Patients With Hypertension ? (DEVISE)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Guy AMAH, MD
- 電話番号：+33 0149958088
- メール：guy.amah@aphp.fr
研究場所
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France
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Paris、France、フランス、75010
- Hôpital Lariboisière
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コンタクト：
- Guy AMAH, MD
- 電話番号：+33 0149958088
- メール：guy.amah@aphp.fr
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主任研究者：
- Guy AMAH, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Treated hypertensive men with erectile dysfunction
Treated hypertensive men without erectile dysfunction
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Patients with hypertension without erectile dysfunction
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Subendocardial viability ratio (SEVR)
時間枠：Once, during the day-hospital visit
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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.
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Once, during the day-hospital visit
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Carotid-femoral pulse wave velocity
時間枠：Once, during the day-hospital visit
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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.
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Once, during the day-hospital visit
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Central pulsed pressure
時間枠：Once, during the day-hospital visit
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Central pulse pressure (mmHg) derived noninvasively from the central aortic pressure waveform obtained by radial artery applanation tonometry.
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Once, during the day-hospital visit
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Pulse pressure amplification
時間枠：Once, during the day-hospital visit
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Defined as the ratio of peripheral radial pulse pressure to central aortic pulse pressure.
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Once, during the day-hospital visit
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Augmentation index
時間枠：Once, during the day-hospital visit
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Augmentation index (%), calculated as augmentation pressure divided by central aortic pulse pressure and measured by applanation tonometry.
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Once, during the day-hospital visit
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Maximum exercise capacity
時間枠：Once, during the day-hospital visit
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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.
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Once, during the day-hospital visit
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Left ventricular mass index
時間枠：Once, during the day-hospital visit
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Left ventricular mass indexed to body surface area (g/m²), measured by echocardiography.
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Once, during the day-hospital visit
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Coronary calcium score
時間枠：Once, during the day-hospital visit
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Agatston coronary artery calcium score obtained from non-contrast cardiac computed tomography.
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Once, during the day-hospital visit
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High-sensitivity C-reactive protein
時間枠：Once, during the day-hospital visit
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Plasma high-sensitivity C-reactive protein concentration measured from a venous blood sample.
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Once, during the day-hospital visit
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SCORE2 and SCORE2-OP
時間枠：Once, during the day-hospital visit
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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.
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Once, during the day-hospital visit
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SF-12 quality-of-life scores
時間枠：Once, during the day-hospital visit
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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.
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Once, during the day-hospital visit
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協力者と研究者
出版物と役立つリンク
一般刊行物
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研究の完了 (推定)
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