| Study characteristics |
| Methods |
Study design: parallel RCT Study duration: November 2014 to July 2017 Follow‐up period: 40 weeks |
| Participants |
Setting: multicentre (number of sites not reported) Country: USA Relevant health status: CKD‐5D on HD Number: treatment group (78); control group (51) Mean age ± SD: 55.5 ± 12.0 years Sex (M/F); 85/44 Exclusion criteria: serum potassium ≥ 6.5 mEq/L or unscheduled dialysis for hyperkalaemia within 3 months; potassium ≥ 6.0 mEq/L within 2 weeks prior to baseline; pre‐dialysis SBP < 100 mm Hg within 2 weeks prior to screening or at baseline; ≥ 2 dialysis sessions within the month prior to screening with BP < 80 mm Hg; treatment for cramping, light‐headedness, nausea, or hypotension; use of digoxin, spironolactone, eplerenone, or dual use of ACEI and ARB; allergy to spironolactone; inability to maintain dialysis machine blood flow ≥ 300 mL/min during the 3 sessions before screening; anticipated pregnancy, transplantation, modality transfer, or transfer to a nonparticipating dialysis unit within 9 months; history of mitral valve surgery or severe mitral valve disease were excluded because of anticipated inability to determine mitral annular E` velocity |
| Interventions |
Treatment group
Spironolactone: 12.5 mg/day (27) for 36 weeks Spironolactone 25 mg/day (26) for 26 weeks Spironolactone 50 mg/day (25) for 36 weeks
Control group
|
| Outcomes |
|
| Identification |
Authors name: David Charytan Institution: Brigham & Women's Hospital Email: dcharytan@bwh.harvard.edu Address: 1620 Tremont Street, 3‐012L, Boston, Massachusetts, USA |
| Notes |
Funding source: This trial was funded by the following cooperative agreements from the National Institute of Diabetes and Digestive and Kidney Diseases: U01 DK096189, U01 DK099923, U01 DK099914, and U01DK099919. Additional support was provided by the Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health Award UL1TR001102) and financial contributions from Harvard University and its affiliated academic health care centres. AMH was supported byI01CX000982 CSR&D. The SEEQ Mobile Cardiac Telemetry (MCl) Systems used for heart rate and rhythm monitoring were donated by Medtronic Inc Complete follow‐up: treatment group (67/78, 85.9%); control group (48/51, 94.1%) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Using a random number generator, the data coordinating centre prepared permuted blocks of random sizes with stratification by centre" |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Web‐based randomisation was performed with participants and all research personnel masked to the treatment assignment." |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "Web‐based randomisation was performed with participants and all research personnel masked to the treatment assignment." |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "Web‐based randomisation was performed with participants and all research personnel masked to the treatment assignment." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing outcome data balanced across intervention groups |
| Selective reporting (reporting bias) |
Low risk |
Quote: "The complete list of primary and secondary outcomes with definitions is provided in Supplementary Table S1." |
| Other bias |
Low risk |
Quote: "This trial was funded by the following cooperative agreements from the National Institute of Diabetes and Digestive and Kidney Diseases: U01DK096189, U01DK099923, U01DK099914, and U01DK099919." |
