RCT on effect of fluid restriction on quality of life in chronic HF
ACC.25 – In FRESH-UP, restricting fluid intake to 1.5 L/day for 3 months did not affect the quality of life of chronic HF patients but did lead to more thirst distress than liberal fluid intake. There were no safety risks.
This summary is based on the presentation of Roland van Kimmenade, MD, PhD (Nijmegen, the Netherlands) at the ACC.25 Scientific Session - Liberal Fluid Intake Versus Fluid Restriction In Chronic Heart Failure.
Introduction and methods
Patients with chronic HF are often advised to limit their fluid intake, but evidence from RCTs supporting this recommendation is scarce. In addition, this advice may adversely impact the patient’s quality of life.
The FRESH-UP (Fluid REStriction in Heart Failure vs Liberal Fluid UPtake) trial was a multicenter open-label RCT conducted in the Netherlands in which 504 outpatients with chronic HF (NYHA class II–III HF symptoms) were randomized to liberal fluid intake or fluid restriction of 1.5 L/day for 3 months. The primary endpoint was quality of life, as assessed with the KCCQ – Overall Summary Score (OSS), at 3 months. The key secondary endpoint was thirst distress, as assessed with the Thirst Distress Scale for patients with HF (TDS‐HF) score, at 3 months. Safety assessment included the incidences of death, all-cause or unplanned HF hospitalization, and use of intravenous loop diuretics, assessed at 3 and 6 months.
Main results
- At 3 months, the mean KCCQ-OSS was 74.0 (95%CI: 71.5–76.6) in patients randomized to liberal fluid intake and 72.2 (95%CI: 69.6–74.7) in those assigned fluid restriction (mean difference adjusted for baseline values: 2.17; 95%CI: –0.06 to 4.39; P=0.06).
- The TDS‐HF score was 16.9 (15.8–18.0) in the liberal fluid–intake group and 18.6 (17.5–19.6) in the fluid-restriction group (P<0.001).
- There were no differences in safety outcomes at 6 months between the 2 groups (all P>0.05).
Conclusion
The Dutch FRESH-UP trial indicated fluid restriction for 3 months did not affect the quality of life of patients with chronic HF, but they did experience more thirst distress than those assigned to liberal fluid intake. There were no concerns about the safety of the restrictive policy in terms of risk of mortality or hospitalization. Dr. Van Kimmenade concluded that “the FRESH-UP study questions the benefit of fluid restriction in chronic HF.”
- Our reporting is based on the information provided at the ACC.25 Scientific Session -