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. 2021 Feb 15;2021(2):CD013109. doi: 10.1002/14651858.CD013109.pub2

Feniman De Stefano 2015.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: March 2011 to December 2012

  • Follow‐up period: 24 weeks

Participants
  • Setting: single centre

  • Country: Brazil

  • Relevant health status: CKD‐5D on HD; stable antihypertensive treatment in the last 6 months

  • Number (randomised/analysed): treatment group (10/8); control group (9/9)

  • Mean age ± SD (years): treatment group (52.0 ± 19.2); control group (56.0 ± 10.9)

  • Sex (M/F): treatment group (4/4); control group (5/4)

  • Exclusion criteria: dialysis dose measured by Kt/V < 1.2; history or evidence of angina or MI, heart failure, peripheral vascular disease, previous hyperkalaemia, valvular heart disease, atrial fibrillation; Hb < 10 g/dL; patients under treatment with spironolactone

Interventions Treatment group
  • Spironolactone: 25 mg/day for 24 weeks


Control group
  • Placebo for 24 weeks

Outcomes
  • LVM

  • EF

  • Serum potassium

Identification
  • Authors name: Greicy Mara Mengue Feniman‐De‐Stefano

  • Institution: Dpto de Clínica Médica da Faculdad

  • Email: gmmfds@yahoo.com.br

  • Address: UNESP, 440 Rua João Miguel Rafael, Botucatu, CEP 18602‐220, São Paulo, Brazil

Notes
  • Funding source: Funded by FUNDUNESP (Foundation for the Development of UNESP, Process 0090910) and FAPESP (Foundation for Research Support of São Paulo, Process 2010/10439‐1)

  • Complete follow‐up: treatment group (8/10, 80%); control group (9/9, 100%)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only states the study was randomised, does not ensure how sequence generation was done
Allocation concealment (selection bias) Unclear risk Only states the study was randomised, does not ensure how allocation concealment was done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "double‐blind", "placebo‐controlled"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "double‐blind", "placebo‐controlled"
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing outcome data balanced across intervention groups
Selective reporting (reporting bias) Low risk All prespecified outcomes have been reported in ClinicalTrials.gov identifier NCT01128101
Other bias Low risk Funded by FUNDUNESP (Foundation for the Development of UNESP, Process 0090910) and FAPESP (Foundation for Research Support of São Paulo, Process 2010/10439‐1)