Rationale and design of the myocardial microinjury and cardiac remodeling extension study in the sodium lowering in dialysate trial (Mac-SoLID study)

BMC Nephrology

Mark Roger Marshall⁶  David John Semple¹  John Benedict William Schollum⁷  Kannaiyan Samuel Rabindranath⁵  David Owen Ross McGregor³  Philip James Matheson⁴  John Hamilton Irvine³  Christopher John Hood⁶  Imad Adbi Haloob¹  Lukas Mathias Gerber⁸  Ruvin Sampath Gabriel²  Janak Rashme de Zoysa⁸  Alain Charles Vandal⁹  Joanna Leigh Dunlop⁶ 

[1]Department of Renal Medicine, Auckland City Hospital, Auckland District Health Board, Private Bag 92024, Auckland 0740, New Zealand

[2]Department of Cardiology, Middlemore Hospital, Counties Manukau District Health Board, Private Bag 93311, Otahuhu, Auckland 1640, New Zealand

[3]Department of Nephrology, Christchurch Hospital, Canterbury District Health Board, Private Bag 4710 Christchurch, New Zealand

[4]Department of Nephrology, Wellington Hospital, Wellington, New Zealand

[5]Department of Renal Medicine, Waikato Hospital, Waikato District Health Board, Private Bag 3200, Hamilton 3240, New Zealand

[6]Department of Renal Medicine, Middlemore Hospital, Counties Manukau District Health Board, Private Bag 93311, Otahuhu, Auckland 1640, New Zealand

[7]Nephrology Service, Dunedin Hospital, Southern District Health Board, 201 Great King St, Dunedin, New Zealand

[8]Renal Service, North Shore Hospital, Waitemata District Health Board, Private Bag 93503, Takapuna, Auckland 0740, New Zealand

[9]Ko Awatea, Middlemore Hopsital, Counties Manukau District Health Board, Private Bag 93311, Otahuhu, Auckland 1640, New Zealand

关键词: Dialysate;    Intra-dialytic hypotension;    Blood pressure;    Sodium;    Myocardial stunning;    Left ventricular remodelling;    Left ventricular mass;    Dialysis;    Self-care hemodialysis;    Home hemodialysis;   

Others  :  1082653
DOI  :  10.1186/1471-2369-15-120

 received in 2014-06-28, accepted in 2014-07-14,  发布年份 2014

【 摘 要 】

Background

The Sodium Lowering in Dialysate (SoLID) trial is an ongoing a multi-center, prospective, randomised, single-blind (assessor), controlled, parallel assignment clinical trial, enrolling 96 home and self-care hemodialysis (HD) patients from 7 centers in New Zealand. The trial will evaluate the hypothesis that lower dialysate [Na+] during HD results in lower left ventricular (LV) mass. Since it’s inception, observational evidence has suggested increased mortality risk with lower dialysate [Na+], possibly due to exacerbation of intra-dialytic hypotension and subsequent myocardial micro-injury. The Myocardial Micro-injury and Cardiac Remodeling Extension Study in the Sodium Lowering In Dialysate Trial (Mac-SoLID study) aims to determine whether lower dialysate [Na+] results in (i) increased levels of high-sensitivity Troponin T (hsTnT), a well-established marker of intra-dialytic myocardial micro-injury in HD populations, and (ii) increased fixed LV segmental wall motion abnormalities, a marker of recurrent myocardial stunning and micro-injury, and (iii) detrimental changes in LV geometry due to maladaptive homeostatic mechanisms.

Methods/design

The SoLID trial and the Mac-SoLID study are funded by the Health Research Council of New Zealand. Key exclusion criteria: patients who dialyse > 3.5 times per week, pre-dialysis serum sodium <135 mM, and maintenance haemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials that contraindicate the study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will receive dialysate sodium 135 mM and 140 mM respectively, for 12 months. The primary outcome measure for the Mac-SOLID study is repeated measures of [hsTnT] at 0, 3, 6, 9, and 12 months. The secondary outcomes will be assessed using cardiac magnetic resonance imaging (MRI), and comprise LV segmental wall motion abnormality scores, LV mass to volume ratio and patterns of LV remodeling at 0 and 12 months.

Discussion

The Mac-SoLID study enhances and complements the SoLID trial. It tests whether potential gains in cardiovascular health (reduced LV mass) which low dialysate [Na+] is expected to deliver, are counteracted by deterioration in cardiovascular health through alternative mechanisms, namely repeated LV stunning and micro-injury.

Trial registration

Australian and New Zealand Clinical Trials Registry number: ACTRN12611000975998.

【 授权许可】

   
2014 Dunlop et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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