Introduction: Fluid restriction (FR) in heart failure (HF) is controversial and outcomes associated with varying prescribed levels are unknown.
Hypothesis: FR groups will demonstrate less congestion (b-natriuretic peptide [BNP] and Congestion Score [CS]), decreased symptom burden (Heart Failure Symptom Survey [HFSS] and Thirst Distress Score [TDS]), improved functional status (6 minute walk test [6MWT]), and QOL (Minnesota Living with Heart Failure [MLWHF]; EQ5D) at 1 and 3 months (m) controlling for NYHA class.
Methods: HF Patients (n=87) were randomized at hospital discharge to 1.5L/day (1.5FR), 2.5L/day (2.5FR), or control (C) groups. All received structured HF education, and FR groups received a comprehensive educational and behavioral intervention (CEBI) to assist FR self-management. Multilevel mixed models were used to test for group, time and group-by-time effects for each outcome followed by post hoc pairwise differences.
Results: HF patients were 51.5 ± 13.3 years, 58.6% men, 75.9% Black, and NYHA class II (40%) and III (60%). Groups did not differ at baseline on demographic or clinical factors, including prescribed furosemide equivalents (p=.42). Reported fluid intake averaged about 2L for all groups at baseline and while there was no significant differences in fluid intake over time or by group, post hoc tests showed 1.5FR decreased to an average of 1566 ml/ day while the C group average increased to 2341ml /day (p=.03) at 3m. Serum sodium levels were within normal ranges for all groups at all time points. All groups improved outcome measures over time without group differences for BNP, CS, TDS, MLWHF, or EQ5D, however, 1.5FR had a significant decrease in total symptoms from baseline to 1m and 3m (p≤.01), with HFSS scores lower than the C group(p<.05) on all 4 symptom domains at 3m. A significant group-by-time effect (p=.04) was observed on the 6MWT with mean distances > 984 feet by 3m in both FR groups; the 1.5FR had a greater percentage (67%) of subjects > 984 feet at 3m trending toward significance (p=.08).
Conclusion: This pilot study supports that a prescribed 1.5L FR coupled with a CEBI may improve adherence with the FR, decrease symptom burden, and improve functional status in persons with NYHA class II and II HF without adversely affecting TDS or QOL.