Chronic Heart Failure Treating Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Table 28: PICO characteristics of review question Population People diagnosed with heart failure according to the New York Heart Association (NYHA) class system (I-IV), who are being managed as outpatients or in the community. Where possible, results will be stratified based on the serum sodium level of patients at baseline. Interventions / Comparisons Salt and/or fluid restriction programme structured, protocol-driven programme to limit salt and/or fluid to certain levels. Programme may or may not be individualised. General advice to limit salt and/or fluid intake No advice to limit salt and/or fluid intake Interventions compared to each other Outcomes CRITICAL Quality of life at 12 months (Continuous) Unplanned hospitalization (Count rate) IMPORTANT Change in weight at 12 months (Continuous) Change in oedema at 12 months (Continuous) Change in sodium level (Continuous)(in the low baseline sodium strata only) Adverse events - Renal function at 12 months (Dichotomous) Adverse events - Hyperkalaemia at 12 months (Dichotomous) Study design Systematic Review RCT 6.1.1.3 Clinical evidence A search was conducted for randomised control trials looking at the effect of sodium (salt) and/or fluid restriction in people with heart failure being managed in the community. Two studies were included in the review70, 281 these are summarised in Table 29. See also the study selection flow chart in Appendix C, forest plots in Appendix E, study evidence tables in Appendix F, GRADE tables in Appendix H and excluded studies list in Appendix I. Both studies are small, and refer to themselves as pilot studies. One study compared a moderate salt intake (2300mg/day sodium) with low salt intake (1500mg/day sodium) in people with HF and normal serum sodium. 