Artery Research

In Press, Corrected Proof, Available Online: 17 July 2020

Protocol of the SPARTE Study: A Strategy for Preventing Cardiovascular and Renal Events based on ARTErial Stiffness

Authors
Stephane Laurent1, 2, *, ORCID, Gilles Chatellier1, 2, 3, Michel Azizi1, 2, 4, 5, David Calvet6, 7, Gabriel Choukroun8, 9, Nicolas Danchin1, 2, 10, Pascal Delsart11, ORCID, Philippe Gosse12, ORCID, Gerard London13, Jean-Jacques Mourad14, Bruno Pannier13, Helena Pereira3, Dominique Stephan15, 16, Pierre Boutouyrie1, 2, 17, On Behalf of SPARTE Investigators
1University of Paris, Paris, France
2Assistance-Publique Hopitaux de Paris, Georges Pompidou European Hospital, Paris, France
3Clinical Research Unit, INSERM, U970, Paris, France
4Hypertension Department and DMU CARTE, Paris, France
5INSERM, CIC1418, Paris, France
6Neurology Department, GHU Paris Psychiatrie Neurosciences, Sainte-Anne Hospital, Paris, France
7INSERM UMR 1266, FHU NeuroVasc, Paris, France
8Nephrology Dialysis Transplantation Department, CHU Amiens, France
9MP3CV Research Unit, University Picardie Jules Verne, France
10Cardiology Department, Georges Pompidou Hospital, Paris, France
11CHU Lille, Institut Cœur Poumon, Lille, France
12Service de Cardiologie/Hypertension Arterielle, Hospital Saint ANDRE, Centre Hospitalier Universitaire de Bordeaux, France
13Department of Nephrology, Manhes Hospital, Fleury Merogis, France
14Groupe Hospitalier Paris Saint-Joseph, Paris, France
15University of Strasbourg, Strasbourg, France
16UMR 1260, INSERM-Université of Strasbourg, Strasbourg, France
17Cardiovascular Research Center – PARCC, Paris, France

The list of all centers is given in Supplementary file.

*Corresponding author. Email: stephane.laurent@aphp.fr
Corresponding Author
Stephane Laurent
Received 26 May 2020, Accepted 4 July 2020, Available Online 17 July 2020.
DOI
https://doi.org/10.2991/artres.k.200711.001How to use a DOI?
Keywords
Antihypertensive drugs, arterial stiffness, cardiovascular events, clinical trial, hypertension
Abstract

Whether arterial stiffness is a surrogate end-point for cardiovascular and renal disease has never been directly demonstrated by a controlled clinical trial. Our main hypothesis is a better prevention of outcomes in high risk hypertensives with PWV normalization driven strategy than with usual blood pressure driven therapeutic strategy based on European Society of Hypertension–European Society of Cardiology (ESH–ESC) guidelines. The strategy for preventing cardiovascular and renal events based on arterial stiffness study is a multicenter open-label randomized controlled trial with blinded endpoint evaluation comparing a therapeutic strategy targeting the normalisation of Pulse Wave Velocity (PWV group) versus a classical therapeutic strategy only implementing the ESH–ESC Guidelines (conventional group), for reducing cardiovascular and renal events. Patients with primary hypertension, aged 55–75 years, and at medium-to-very high cardiovascular risk will be included and followed-up for 4 years. In the PWV group, treatment will be adjusted to carotid-femoral PWV measured every 6 months. In the conventional group, PWV will be measured at baseline and every 2 years, but its value will be blinded to the investigator in charge of the patient. In the PWV group, the therapeutic strategy will preferably use a combination of Angiotensin-converting Enzyme Inhibitor (ACEI) [or Angiotensin Receptor Blockers (ARB)] and calcium channel blockers, as well as maximal recommended doses of ACEIs and ARBs. The primary combined endpoint includes stroke and coronary events (myocardial infarction, angioplasty, bypass), fatal or not, peripheral artery disease (angioplasty, bypass, amputation), hospitalization for heart failure, aortic dissection, chronic kidney disease (doubling of creatinine, dialysis), and sudden death. Twenty-five research centers will include a total of 1500 patients, in order to show a 20% reduction in the primary combined endpoint - the incidence of which is estimated at 10% per year - in the PWV group compared to the conventional group.

Copyright
© 2020 Association for Research into Arterial Structure and Physiology. Publishing services by Atlantis Press International B.V.
Open Access
This is an open access article distributed under the CC BY-NC 4.0 license (http://creativecommons.org/licenses/by-nc/4.0/).

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Journal
Artery Research
Publication Date
2020/07
ISSN (Online)
1876-4401
ISSN (Print)
1872-9312
DOI
https://doi.org/10.2991/artres.k.200711.001How to use a DOI?
Copyright
© 2020 Association for Research into Arterial Structure and Physiology. Publishing services by Atlantis Press International B.V.
Open Access
This is an open access article distributed under the CC BY-NC 4.0 license (http://creativecommons.org/licenses/by-nc/4.0/).

Cite this article

TY  - JOUR
AU  - Stephane Laurent
AU  - Gilles Chatellier
AU  - Michel Azizi
AU  - David Calvet
AU  - Gabriel Choukroun
AU  - Nicolas Danchin
AU  - Pascal Delsart
AU  - Philippe Gosse
AU  - Gerard London
AU  - Jean-Jacques Mourad
AU  - Bruno Pannier
AU  - Helena Pereira
AU  - Dominique Stephan
AU  - Pierre Boutouyrie
AU  - On Behalf of SPARTE Investigators
PY  - 2020
DA  - 2020/07
TI  - Protocol of the SPARTE Study: A Strategy for Preventing Cardiovascular and Renal Events based on ARTErial Stiffness
JO  - Artery Research
SN  - 1876-4401
UR  - https://doi.org/10.2991/artres.k.200711.001
DO  - https://doi.org/10.2991/artres.k.200711.001
ID  - Laurent2020
ER  -