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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 Nephrol. 2012 Oct 19; 13:137.BN

Abstract

BACKGROUND

Despite 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/DESIGN

The 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.

DISCUSSION

The 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 REGISTRATION

Universal Trial Number: U1111-1125-2149. Australian New Zealand Clinical Trials Registry Number: ACTRN12611001097932.

Authors+Show Affiliations

Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Brisbane, QLD, 4102, Australia. e.hall5@uq.edu.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23082956

Citation

McMahon, Emma J., et al. "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, vol. 13, 2012, p. 137.
McMahon EJ, Bauer JD, Hawley CM, et al. 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 Nephrol. 2012;13:137.
McMahon, E. J., Bauer, J. D., Hawley, C. M., Isbel, N. M., Stowasser, M., Johnson, D. W., Hale, R. E., & Campbell, K. L. (2012). 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, 13, 137. https://doi.org/10.1186/1471-2369-13-137
McMahon EJ, et al. 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 Nephrol. 2012 Oct 19;13:137. PubMed PMID: 23082956.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - McMahon,Emma J, AU - Bauer,Judith D, AU - Hawley,Carmel M, AU - Isbel,Nicole M, AU - Stowasser,Michael, AU - Johnson,David W, AU - Hale,Rachael E, AU - Campbell,Katrina L, Y1 - 2012/10/19/ PY - 2012/10/04/received PY - 2012/10/16/accepted PY - 2012/10/23/entrez PY - 2012/10/23/pubmed PY - 2013/9/4/medline SP - 137 EP - 137 JF - BMC nephrology JO - BMC Nephrol VL - 13 N2 - BACKGROUND: Despite 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/DESIGN: The 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. DISCUSSION: The 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 REGISTRATION: Universal Trial Number: U1111-1125-2149. Australian New Zealand Clinical Trials Registry Number: ACTRN12611001097932. SN - 1471-2369 UR - https://www.unboundmedicine.com/medline/citation/23082956/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_ L2 - https://www.biomedcentral.com/1471-2369/13/137 DB - PRIME DP - Unbound Medicine ER -