Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD)

Study protocol for a randomized controlled pilot trial

Khai P. Ng, Poorva Jain, Gurdip Heer, Val Redman, Odette Chagoury, George Dowswell, Sheila Greenfield, Nick Freemantle, Jonathan N. Townend, Paramjit S. Gill, Richard J. McManus, Charles J. Ferro

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: Chronic kidney disease is associated with increased arterial stiffness even in the early stages and this is thought to be a key mediator in the pathophysiology of the increased cardiovascular risk associated with this condition. The use of low-dose spironolactone has previously been shown to improve arterial stiffness and reduce left ventricular mass safely in early-stage chronic kidney disease in the context of careful monitoring at a university hospital. However, the majority of patients with chronic kidney disease are managed by their general practitioners in the community. It is not known whether similar beneficial effects can be achieved safely using spironolactone in the primary care setting. The aim of this study is to determine whether low-dose spironolactone can safely lower arterial stiffness in patients with stage 3 chronic kidney disease in the primary care setting.Methods/design: STOP-CKD is a multicentre, prospective, randomized, double-blind, placebo-controlled pilot trial of 240 adult patients with stage 3 chronic kidney disease recruited from up to 20 general practices in South Birmingham, England. Participants will be randomly allocated using a secured web-based computer randomization system to receive either spironolactone 25 mg once daily or a matching inactive placebo for 40 weeks, followed by a wash-out period of 6 weeks. Investigators, outcome assessors, data analysts and participants will all be blinded to the treatment allocation. The primary endpoint is improved arterial stiffness, as measured by carotid-femoral pulse wave velocity between baseline and 40 weeks. The secondary endpoints are incidence of hyperkalaemia, change in estimated glomerular filtration rate, change in urine albumin:creatinine ratio, change in brachial blood pressure, change in pulse waveform characteristics and overall tolerability of spironolactone. An additional quality control study, aiming to compare the laboratory serum potassium results of samples processed via two methods (utilizing routine transport or centrifugation on site before rapid transport to the laboratory) for 100 participants and a qualitative research study exploring patients' and general practitioners' attitudes to research and the use of spironolactone in chronic kidney disease in the community setting will be embedded in this pilot study.Trial registration: Current Controlled Trials ISRCTN80658312.

Original languageEnglish
Article number158
JournalTrials
Volume15
Issue number1
DOIs
Publication statusPublished - 6 May 2014
Externally publishedYes

Fingerprint

Spironolactone
Chronic Renal Insufficiency
Vascular Stiffness
Randomized Controlled Trials
General Practitioners
Primary Health Care
Placebos
Pulse Wave Analysis
Hyperkalemia
Qualitative Research
Computer Systems
Random Allocation
Thigh
Glomerular Filtration Rate
Centrifugation
General Practice
England
Quality Control
Pulse
Albumins

Keywords

  • arterial stiffness
  • cardiovascular events
  • chronic kidney disease
  • feasibility
  • mineralocorticoid receptor antagonist
  • pulse wave velocity
  • qualitative
  • randomized controlled trial
  • renal dysfunction
  • spironolactone

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)
  • Medicine(all)

Cite this

Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD) : Study protocol for a randomized controlled pilot trial. / Ng, Khai P.; Jain, Poorva; Heer, Gurdip; Redman, Val; Chagoury, Odette; Dowswell, George; Greenfield, Sheila; Freemantle, Nick; Townend, Jonathan N.; Gill, Paramjit S.; McManus, Richard J.; Ferro, Charles J.

In: Trials, Vol. 15, No. 1, 158, 06.05.2014.

Research output: Contribution to journalArticle

Ng, KP, Jain, P, Heer, G, Redman, V, Chagoury, O, Dowswell, G, Greenfield, S, Freemantle, N, Townend, JN, Gill, PS, McManus, RJ & Ferro, CJ 2014, 'Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): Study protocol for a randomized controlled pilot trial', Trials, vol. 15, no. 1, 158. https://doi.org/10.1186/1745-6215-15-158
Ng, Khai P. ; Jain, Poorva ; Heer, Gurdip ; Redman, Val ; Chagoury, Odette ; Dowswell, George ; Greenfield, Sheila ; Freemantle, Nick ; Townend, Jonathan N. ; Gill, Paramjit S. ; McManus, Richard J. ; Ferro, Charles J. / Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD) : Study protocol for a randomized controlled pilot trial. In: Trials. 2014 ; Vol. 15, No. 1.
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