Strategy for Preventing Cardiovascular and Renal Events Based on ARTErial Stiffness

NCT02617238 | Unknown

• 1 other identifier: K110102
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

arterial stiffness; cardiovascular risk; cardiovascular events; renal events

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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)

  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

Study Arms (2)

PWV group

ACTIVE COMPARATOR

Cardiovascular risk management based on PWV will include altogether 1. the implementation of international guidelines, 2. the normalisation of blood pressure, and 3. the normalisation of arterial stiffness

Other: Cardiovascular risk management based on PWV

Conventional group

NO INTERVENTION

These patients will be treated according to the 2007 (and then 2013) ESH-ESC Guidelines for the management of hypertension

Interventions

Cardiovascular risk management based on PWV OTHER

Arterial stiffness will be measured through the determination of the carotid-femoral pulse wave velocity (PWV). 1. In the "PWV group", PWV will be measured at baseline, and then every 6 months. PWV measurement will guide the intensification of treatment. Measurements will be immediately available to the physician in charge of the patient, in order to adapt treatment. The therapeutic strategy is based both on the normalisation of BP and then on the BP-independent reduction in PWV, using commercially available antihypertensive medications. 2. In the "conventional group", PWV will be measured at baseline, after 2 years, and at the end of the study. PWV values will be masked to the physician

PWV group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• registration to the French social security system
• patients who did not specifically express their non willingness to participate
• 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/DBP over 130/85 mmHg
• HDL-C \<1.0 mmol/l (0,4 g/l) (M) or \< 1.2 mmol/l (0,46 g/l) (F)
• Triglycerides \>1,7 mmol/l (\>1,5 g/l)
• Fasting blood glucose 5,6 - 6,9 mmol/l (1,02-1,25 g/l)
• Waist circumference \> 102 cm (M) ou 88 cm (F) or Type 2 diabetes or Target organ damage, according to the definition of the ESH-ESC Guidelines for the Management of Hypertension or CV disease or chronic kidney disease
• SBP \> 180 mmHg and/or DBP \> 110 mmHg
• SBP \> 160 mmHg AND DBP \< 70 mmHg

You may not qualify if:

• Patients with ABPM or self-measurement normal without treatment (\<130 mmHg and 80 in the ABPM 24 or \<135 and 85 mmHg or daytime ABPM self-measurement of blood pressure)
• Patients with secondary hypertension (renal artery stenosis, pheochromocytoma, or hypermineralocortisism)
• Patients with hypertension secondary to diabetic nephropathy
• Patients aged under 55 or over 75 years,
• Low-risk CV patients
• Patients with severe chronic renal impairment creatinine clearance (MDRD) \<30ml / min / 1.73m2
• Patients with type I diabetes
• Patients with severe disease threatening the vital prognosis in the short and medium terms
• Patients who previously experienced a painful gynecomastia under spironolactone
• Patients with alcohol dependence or excessive consumption alcoholic beverages (at the judgement of the investigator)
• patients with accident history neurovascular, coronary insufficiency (coronary bypass surgery or percutaneous coronary intervention) not older than 3 month
• Patients with a history of acute heart failure or having open failure heart (NYHA class III-IV)
• Patients with unstable angina
• Auricular Fibrillation (AF) less than 6 months ago
• Patients with aortic stent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• Fondation pour la Recherche en Hypertension Artérielle: collaborator

Study Sites (1)

Clinical Investigation Center, Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Related Publications (3)

• 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.

  PMID: 22733473 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.

  PMID: 17000623 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.

  PMID: 17563527 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: November 30, 2015
• Study Start: July 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

FR (1)