Hypertension Clinical Trial
Official title:
Strategy for Preventing Cardiovascular and Renal Events Based on ARTErial Stiffness
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
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