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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Fondation pour la Recherche en Hypertension Artérielle | OTHER |
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Randomised two parallel groups multicenter study using a Prospective Randomised Open Blinded End-point design (PROBE), aiming at comparing the efficacy of a therapeutic strategy targeting the normalisation of arterial stiffness for reducing cardiovascular (CV) and renal events, in comparison with a classical therapeutic strategy implementing the European Society of Hypertension-European Society of Cardiology (ESH-ESC) Guidelines, in patients with essential hypertension and medium-to-very high CV risk.
The objective is to show that a therapeutic strategy targeting the implementation of international guidelines PLUS the normalisation of blood pression (BP < 140 and 90 mmHg) plus the normalisation of arterial stiffness (measured every 6 months) Pulse Wave Velocity group (PWV group) reduces CV and renal events to a significantly greater extent than the sole implementation of Guidelines (conventional group, with PWV measurement at baseline and every 2 years).
Experimental design: Prospective Randomised Open Blinded Endpoint (PROBE) multicenter, two parallel groups, study.
Therapeutic strategy in the PWV group:
Therapeutic strategy in the conventional group: Apply the ESH-ESC Guidelines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PWV group | Active Comparator | Cardiovascular risk management based on PWV will include altogether
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| Conventional group | No Intervention | These patients will be treated according to the 2007 (and then 2013) ESH-ESC Guidelines for the management of hypertension |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular risk management based on PWV | Other | Arterial stiffness will be measured through the determination of the carotid-femoral pulse wave velocity (PWV).
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| Measure | Description | Time Frame |
|---|---|---|
| Number of cardiovascular and renal events | The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, non-fatal myocardial Infarction, non-fatal stroke, adverse renal outcome (defined by chronic dialysis, kidney transplantation, or doubling of serum creatinine) and hospitalization for any of the following causes: angioplasty or bypass surgery for coronary or peripheral vessel disease, congestive heart failure, or aortic dissection. An independent committee will validate the events and causes blinded treatment received | 4 years of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of non-fatal myocardial Infarction | 4 years follow-up | |
| Number of non-fatal stroke | 4 years follow-up | |
| Number of adverse renal outcome (defined by chronic dialysis, kidney transplantation, or doubling of serum creatinine) |
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Inclusion Criteria:
PLUS either A, B or C:
Patients with essential hypertension, aged 55 to 75 years old, both sexes
Grade 1 hypertension of more
Treated or not
Whatever the control of BP
Under primary of secondary prevention (more than 3 months stroke or myocard infarctus (MI), or stable angina or peripheral artery disease) PLUS at least 3 CV risk factors according to ESH-ESC 2007 guidelines or metabolic syndrome associating at least 2 of the following criteria
SBP > 180 mmHg and/or DBP > 110 mmHg
SBP > 160 mmHg AND DBP < 70 mmHg
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephane LAURENT, MD, PhD | Hopital Europen Georges Pompidou, Assistance publique Hopitaux de Paris | Principal Investigator |
| Pierre BOUTOUYRIE, MD, PhD | Hopital Europen Georges Pompidou, Assistance publique Hopitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Center, Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22733473 | Background | Laurent S, Briet M, Boutouyrie P. Arterial stiffness as surrogate end point: needed clinical trials. Hypertension. 2012 Aug;60(2):518-22. doi: 10.1161/HYPERTENSIONAHA.112.194456. Epub 2012 Jun 25. No abstract available. | |
| 17000623 | Background | Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 4 years follow-up |
| Number of hospitalization for any of the following causes: angioplasty or bypass surgery for coronary or peripheral vessel disease | 4 years follow-up |
| Number of congestive heart failure | 4 years follow-up |
| Number of aortic dissection | 4 years follow-up |
| Carotid-femoral pulse wave velocity (PWV) value at the end of the study | 4 years follow-up |
| Central systolic blood pressure value | 4 years follow-up |
| Central pulse pressure value | 4 years follow-up |
| 17563527 | Background | Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available. |