MedTrace Logo

Strategy for Preventing Cardiovascular and Renal Events Based on ARTErial Stiffness

NCT02617238 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2017-03-01

No results posted yet for this study

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

Interventions

OTHER

Cardiovascular risk management based on PWV

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Fondation pour la Recherche en Hypertension Artérielle

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Stephane LAURENT, MD, PhD · Hopital Europen Georges Pompidou, Assistance publique Hopitaux de Paris

  • Pierre BOUTOUYRIE, MD, PhD · Hopital Europen Georges Pompidou, Assistance publique Hopitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02617238 on ClinicalTrials.gov