Conceptual basis and methodology of the SOPHIA study

N. Glorioso, G. Argiolas, F. Filigheddu, C. Troffa, F. Cocco, E. Bulla, P. Bulla, R. Zaninello, S. Degortes, S. Pitzoi, F. Frau, S. Fadda, P. Pinna Parpaglia, G. Bernini, M. Bardini, F. Fallo, L. Malatino, G. Regolisti, C. Ferri, D. CusiA. Sciacqua, F. Perticone, E. Degli Esposti, C. Baraccani, G. Parati, F. Veglio, P. Mulatero, T. A. Williams, F. Macciardi, B. Stancanelli

Research output: Contribution to journalArticle

Abstract

To clarify the role of gene polymorphisms on the effect of losartan and losartan plus hydrochlorothiazide on blood pressure (primary end point) and on cardiac, vascular and metabolic phenotypes (secondary end point) after 4, 8, 12, 16 and 48 weeks treatment, an Italian collaborative study - The Study of the Pharmacogenomics in Italian hypertensive patients treated with the Angiotensin receptor blocker losartan (SOPHIA) - on never-treated essential hypertensives (n = 800) was planned. After an 8 week run-in, losartan 50 mg once daily will be given and doubled to 100 mg at week +4 if blood pressure is more than 140/90 mmHg. Hydroclorothiazide 251 mg once daily at week +8 and amlodipine 5 mg at week +16 will be added if blood pressure is more than 140/90 mmHg. Cardiac mass (echocardiography), carotid intima-media thickness, 24 h ambulatory blood pressure, homeostatic model assessment (HOMA) index, microalbuminuria, plasma renin activity and aldosterone, endogenous lithium clearance, brain natriuretic peptide and losartan metabolites will be evaluated. Genes of the renin-angiotensin-aldosterone system, salt sensitivity, the β-adrenergic system and losartan metabolism will be studied (Illumina custom arrays). A whole-genome scan will also be performed in half of the study cohort (1M array, Illumina 500 GX beadstation).

Original languageEnglish
Pages (from-to)1497-1509
Number of pages13
JournalPharmacogenomics
Volume8
Issue number11
DOIs
Publication statusPublished - Nov 2007

Keywords

  • Drug therapy
  • Gene polymorphisms
  • High blood pressure
  • Pharmacogenomics
  • Renin angiotensin system
  • Whole-genome scan

ASJC Scopus subject areas

  • Pharmacology
  • Genetics(clinical)

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  • Cite this

    Glorioso, N., Argiolas, G., Filigheddu, F., Troffa, C., Cocco, F., Bulla, E., Bulla, P., Zaninello, R., Degortes, S., Pitzoi, S., Frau, F., Fadda, S., Parpaglia, P. P., Bernini, G., Bardini, M., Fallo, F., Malatino, L., Regolisti, G., Ferri, C., ... Stancanelli, B. (2007). Conceptual basis and methodology of the SOPHIA study. Pharmacogenomics, 8(11), 1497-1509. https://doi.org/10.2217/14622416.8.11.1497