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

Artery Research volume 26, pages 250–260 (2020)Cite this article

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.

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Authors and Affiliations

  1. University of Paris, Paris, France

    Stephane Laurent, Gilles Chatellier, Michel Azizi, Nicolas Danchin & Pierre Boutouyrie

  2. Assistance-Publique Hopitaux de Paris, Georges Pompidou European Hospital, Paris, France

    Stephane Laurent, Gilles Chatellier, Michel Azizi, Nicolas Danchin & Pierre Boutouyrie

  3. Clinical Research Unit, INSERM, U970, Paris, France

    Gilles Chatellier & Helena Pereira

  4. Hypertension Department and DMU CARTE, Paris, France

    Michel Azizi

  5. INSERM, CIC1418, Paris, France

    Michel Azizi

  6. Neurology Department, GHU Paris Psychiatrie Neurosciences, Sainte-Anne Hospital, Paris, France

    David Calvet

  7. INSERM UMR 1266, FHU NeuroVasc, Paris, France

    David Calvet

  8. Nephrology Dialysis Transplantation Department, CHU Amiens, France

    Gabriel Choukroun

  9. MP3CV Research Unit, University Picardie Jules Verne, France

    Gabriel Choukroun

  10. Cardiology Department, Georges Pompidou Hospital, Paris, France

    Nicolas Danchin

  11. CHU Lille, Institut CÅ“ur Poumon, Lille, France

    Pascal Delsart

  12. Service de Cardiologie/Hypertension Arterielle, Hospital Saint ANDRE, Centre Hospitalier Universitaire de Bordeaux, France

    Philippe Gosse

  13. Department of Nephrology, Manhes Hospital, Fleury Merogis, France

    Gerard London & Bruno Pannier

  14. Groupe Hospitalier Paris Saint-Joseph, Paris, France

    Jean-Jacques Mourad

  15. University of Strasbourg, Strasbourg, France

    Dominique Stephan

  16. UMR 1260, INSERM-Université of Strasbourg, Strasbourg, France

    Dominique Stephan

  17. Cardiovascular Research Center — PARCC, Paris, France

    Pierre Boutouyrie

Authors
  1. Stephane Laurent
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  2. Gilles Chatellier
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  3. Michel Azizi
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  14. Pierre Boutouyrie
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SPARTE Investigators

Corresponding author

Correspondence to Stephane Laurent.

Additional information

The list of all centers is given in Supplementary file.

Peer review under responsibility of the Association for Research into Arterial Structure and Physiology

Data availability statement: The authors confirm that the data supporting the findings of this study are available within the article [and/or] its supplementary materials.

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Laurent, S., Chatellier, G., Azizi, M. et al. Protocol of the SPARTE Study: A Strategy for Preventing Cardiovascular and Renal Events based on ARTErial Stiffness. Artery Res 26, 250–260 (2020). https://doi.org/10.2991/artres.k.200711.001

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Keywords

Artery Research

ISSN: 1876-4401

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