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: 1. 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. 2. In second step, use combination therapy with Calcium channel blockers (CCBs) 3. Use diuretics in combination therapy, either as an alternative to CCBs in second step or as triple therapy in third step 4. Use, as fourth step, vasodilating beta-blockers (VD-BB) or spironolactone 5. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
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
Clinical Investigation Center, Hopital Europeen Georges Pompidou
Paris, France
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
Time frame: 4 years of follow-up
Number of non-fatal myocardial Infarction
Time frame: 4 years follow-up
Number of non-fatal stroke
Time frame: 4 years follow-up
Number of adverse renal outcome (defined by chronic dialysis, kidney transplantation, or doubling of serum creatinine)
Time frame: 4 years follow-up
Number of hospitalization for any of the following causes: angioplasty or bypass surgery for coronary or peripheral vessel disease
Time frame: 4 years follow-up
Number of congestive heart failure
Time frame: 4 years follow-up
Number of aortic dissection
Time frame: 4 years follow-up
Carotid-femoral pulse wave velocity (PWV) value at the end of the study
Time frame: 4 years follow-up
Central systolic blood pressure value
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
3,000
Time frame: 4 years follow-up
Central pulse pressure value
Time frame: 4 years follow-up