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Efficacy of very low dose perindopril 2 mg/indapamide 0.625 mg combination on left ventricular hypertrophy in hypertensive patients: the P.I.C.X.E.L. study rationale and design

Journal of Human Hypertension volume 16, pages 653–659 (2002)Cite this article

Abstract

The PICXEL study is designed to evaluate the effects of long-term administration of very low-dose combination perindopril 2 mg/indapamide 0.625 mg (Per/Ind) vs enalapril in reducing left ventricular hypertrophy (LVH) in hypertensive patients. This multicentre, controlled, randomised, double-blind, parallel group study is carried-out to assess the variation of left ventricular mass index (LVMI) after treatment, using a centralised control of M-mode echocardiography determinations, and a dedicated software for semi-automatic measurement. Following a 4-week placebo run-in period, hypertensive outpatients aged ⩾18 years, with LVH (LVMI >120 and 100 g/m2 for men and women, respectively), are randomised to receive once daily, over 52 weeks, either Per/Ind or enalapril. According to blood pressure levels, the dose may be adjusted. In addition to clinical examinations, ECG, blood pressure, heart rate and laboratory assessments echocardiographic determinations are performed for selection, at baseline, after 24 weeks and at the end of the study. The main outcome criteria is the change from baseline in LVMI which is considered the primary efficacy criterion; changes in blood pressure and echo-Doppler parameters constitute secondary criteria. Two-sided Student's t-test for independent samples will be used to differentiate the effects of the treatment between groups with α = 5%, and the inter-group difference of LVMI variation will be analysed with a power of 90%. A sample size of 500 patients is required making it necessary to randomise at least 550 patients, based on a 10% proportion of potentially non-assessable patients. The results of this study, obtained after applying strict methodological procedures and requirements, are expected to provide valuable and reliable information on the effects of long-term administration of Per/Ind on LVH, and on its potential superiority over enalapril.

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Acknowledgements

We thank IôDP company who developed the software that allow all the semi-automatic measurements and left ventricular mass especially Mr Souheil Mansour and Dr JC Provost. This study is supported by Institut de Recherches Servier.

Author information

Authors and Affiliations

  1. Hop. Saint André, Bordeaux, France

    P Gosse

  2. Hop. A. Paré, Boulogne, France

    O Dubourg

  3. Hop. H. Mondor, Créteil, France

    P Guéret

  4. University Federico II, Napoli, Italy

    G De Simone

  5. Medizinische Klinik IV, Nurnberg, Germany

    R Schmieder

  6. Academisch Ziekenhuis, Maastricht, The Netherlands

    P W De Leeuw

  7. Hop. Erasme, Brussels, Belgium

    J-P Degaute

  8. Hop. La Paz, Madrid, Spain

    J García Puig

  9. Russian Cardiology Research Centre, Moscow, Russia

    Y Karpov

  10. Institut für Hypertoniker, Vienna, Austria

    D Magometschnigg

  11. Hungarian Institute of Cardiology, Budapest, Hungary

    L Matos

  12. Institut Pasteur, Lille, France

    P Amouyel

  13. Institut Cardiovasculaire, Paris, France

    R Asmar

  14. Hop. Européen G. Pompidou, Paris, France

    J-Y Le Heuzey

  15. Helsinki University Hospital., Helsinki, Finland

    M Nieminen

  16. Göteborg University, Göteborg, Sweden

    B Dahlöf

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  1. P Gosse
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  2. O Dubourg
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  3. P Guéret
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  4. G De Simone
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  16. B Dahlöf
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Corresponding author

Correspondence to P Gosse.

Appendix

Appendix

The following persons participated in the PICXEL trial:

Steering Committee: B Dahlöf (International coordinator), JP Degaute (Belgium coordinator), G de Simone, (Italy coordinator), P de Leeuw (Netherlands coordinator), J Garcia Puig (Spain coordinator), P Gosse (France coordinator), Y Karpov (Russia coordinator), D Magometschnigg (Austria coordinator), L Matos (Hungary coordinator), R. Schmieder (Germany coordinator). Central Echocardiographic Committee: P Gosse (Chairman, reviewer in quality/final review), O Dubourg (Reviewer – quality/final review), P Guéret (Reviewer – quality/final review), G de Simone (Reviewer – quality/reproducibility), R Schmieder (Reviewer – reproducibility). Ancillary studies: P Amouyel (genetic chair), R Asmar (ABPM chair), JY Le Heuzey (holter ECG chair), M Nieminen (ECG QT dispersion chair).

Principal Investigators (included patients): Austria (1): D Magometschnigg. Belgium (6): JP Degaute. France (172): JF Allegret, R Caduc, JP Michaux, B Olivieri, JP Becq, J Calazel, L Boucher, T Legendre, S Boutboul, S Aharfi, F Thoin, P Tanielian, A Boye, P du Roscoat, A Campagne L Battle, J Frédéric, B Chagnoux, F Pellerin, A de la Chevasnerie, E Maffert, D Dubourg, A el Sawy, J Pellet, P Maldonado, G Faugas, MT Escourrou, G Grandmottet, D Lejay, V Hennebelle, B Dalle, C Magnani, J Marty, T Schaupp, A Riou, G Mongin, R Crespy, P Guillot, D Ternisien, E Pacé, R Pradeau, M Cautres, J Sicard, P Remplon, F Chombart, HW Spiess, F Spilthooren, T Stefanaggi, P Talarczyk, M Wong Chi Man, J Aubry, JY Brunet, P Giraud, C Cayol, JC Ferrer, D Mery, RP Sarfati, G Lavabre, JF Giudicelli, JP Resch, P Bruneau, D Provensal, G Amabile, R Carlioz, Y Frances, R Luccioni, R Richard. Germany (9): R Krallinger, M Mikolaiczik, A Schreckenberg. Hungary (23): L Matos, L Regos, S Timar. Italy (3): G de Simone, S Pede. Netherlands (7): J Jonker. Russia (433): Y Karpov, G Arabidze, V Dmitriev, B Bart, V Tsyrlin, V Zadionchenko, V Moiseev, E Shlyakhto, R Karpov, N Kuznetsov, R Oganov, B Sidorenko, L Lazebnik, I Komissarenko, Y Belousov, L Olbinskaya, M Glezer, G Aroutiounov, A Vertkin, O Moryleva, D Zateyshchikov, A Avtandilov. Spain (25): J Garcia-Puig, C Calvo.

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Gosse, P., Dubourg, O., Guéret, P. et al. Efficacy of very low dose perindopril 2 mg/indapamide 0.625 mg combination on left ventricular hypertrophy in hypertensive patients: the P.I.C.X.E.L. study rationale and design. J Hum Hypertens 16, 653–659 (2002). https://doi.org/10.1038/sj.jhh.1001467

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