The effect of lowering salt intake on ambulatory blood pressure to reduce cardiovascular risk in chronic kidney disease (LowSALT CKD study): protocol of a randomized trial

BMC Nephrology

Study Protocol

Rachael E Hale¹  Carmel M Hawley¹  Nicole M Isbel¹  Katrina L Campbell²  Emma J McMahon²  Michael Stowasser²  David W Johnson²  Judith D Bauer³ 

[1] Princess Alexandra Hospital, 199 Ipswich Road, 4102, Woolloongabba, Brisbane, QLD, Australia;Princess Alexandra Hospital, 199 Ipswich Road, 4102, Woolloongabba, Brisbane, QLD, Australia;University of Queensland, 4072, Brisbane, Australia;University of Queensland, 4072, Brisbane, Australia;

关键词: Dietary sodium;    Chronic kidney disease;    Blood pressure;    Cardiovascular disease;    Arterial stiffness;    Clinical trial;    Patient compliance;    Taste disturbance;   

DOI  :  10.1186/1471-2369-13-137

 received in 2012-10-04, accepted in 2012-10-16,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundDespite evidence implicating dietary sodium in the pathogenesis of cardiovascular disease (CVD) in chronic kidney disease (CKD), quality intervention trials in CKD patients are lacking. This study aims to investigate the effect of reducing sodium intake on blood pressure, risk factors for progression of CKD and other cardiovascular risk factors in CKD.Methods/designThe LowSALT CKD study is a six week randomized-crossover trial assessing the effect of a moderate (180 mmol/day) compared with a low (60 mmol/day) sodium intake on cardiovascular risk factors and risk factors for kidney function decline in mild-moderate CKD (stage III-IV). The primary outcome of interest is 24-hour ambulatory blood pressure, with secondary outcomes including arterial stiffness (pulse wave velocity), proteinuria and fluid status. The randomized crossover trial (Phase 1) is supported by an ancillary trial (Phase 2) of longitudinal-observational design to assess the longer term effectiveness of sodium restriction. Phase 2 will continue measurement of outcomes as per Phase 1, with the addition of patient-centered outcomes, such as dietary adherence to sodium restriction (degree of adherence and barriers/enablers), quality of life and taste assessment.DiscussionThe LowSALT CKD study is an investigator-initiated study specifically designed to assess the proof-of-concept and efficacy of sodium restriction in patients with established CKD. Phase 2 will assess the longer term effectiveness of sodium restriction in the same participants, enhancing the translation of Phase 1 results into practice. This trial will provide much-needed insight into sodium restriction as a treatment option to reduce risk of CVD and CKD progression in CKD patients.Trial registrationUniversal Trial Number: U1111-1125-2149. Australian New Zealand Clinical Trials Registry Number: ACTRN12611001097932

【 授权许可】

CC BY   
© McMahon et al.; licensee BioMed Central Ltd. 2012