Strategy for Preventing Cardiovascular and Renal Events Based on ARTErial Stiffness
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Number of cardiovascular and renal events
研究概览
简要总结
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.
详细描述
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:
- Use maximal recommended doses of angiotensin-converting-enzyme inhibitor (ACEIs) or Angiotensin II receptor blockers (ARBs) as first step treatment. And then adapt treatment to PWV values.
- In second step, use combination therapy with Calcium channel blockers (CCBs)
- Use diuretics in combination therapy, either as an alternative to CCBs in second step or as triple therapy in third step
- Use, as fourth step, vasodilating beta-blockers (VD-BB) or spironolactone
- In parallel, correct all CV risk factors according to ESH-ESC Guidelines, and reinforce treatment (hypolipidemic drugs, glucose lowering drugs, antiplatelets) if secondary prevention.
Therapeutic strategy in the conventional group: Apply the ESH-ESC Guidelines
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Patients with known aneurysms of the abdominal aorta
- •Patients with atrioventricular block second or third degree without pacemaker
- •Patients having received organ transplant or placed on a waiting list for transplantation
- •Patients with severe chronic inflammatory disease (rheumatoid arthritis; lupus; scleroderma ...)
- •Patients with severe chronic infectious disease
- •Patients who have had an MI less than 3 months ago
- •Patients with stroke there are less than 3 months ago
- •Patients with progression of peripheral arterial disease
- •Patient whose pregnancy is known or which has no effective contraception if is of childbearing age, or if she is breastfeeding
- •Patients who have expressed their opposition to participate in the protocol or have an inability to understand or follow the protocol
- •The patients geographically too far from the place of investigation
- •Patients already participating in other drug research protocol or Interventional
结局指标
主要结局
Number of cardiovascular and renal events
时间窗: 4 years of follow-up
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
次要结局
- 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 aortic dissection(4 years follow-up)
- Central systolic blood pressure value(4 years follow-up)
- Central pulse pressure value(4 years follow-up)
- Number of non-fatal stroke(4 years follow-up)
- Number of non-fatal myocardial Infarction(4 years follow-up)
- Number of adverse renal outcome (defined by chronic dialysis, kidney transplantation, or doubling of serum creatinine)(4 years follow-up)
- Carotid-femoral pulse wave velocity (PWV) value at the end of the study(4 years follow-up)
- Number of congestive heart failure(4 years follow-up)