The aim of this clinical trial is to learn whether a thirst-driven, liberal fluid-intake strategy is comparable to a fluid-restriction strategy in patients hospitalized for acute decompensated heart failure (ADHF). The study will also assess the safety of the intervention and its effects on thirst and quality of life. Patients hospitalized with ADHF will be asked to follow either a thirst-driven fluid-intake strategy or a fluid-restriction strategy during their hospital stay and for one month after discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
420
Fluid restriction of 1.5 L/day
Liberal fluid intake driven by thirst without restrictions
Department of Cardiology, Gødstrup Hospital
Herning, Denmark
Time to clinical stability
Time from randomization to clinical stability. Clinical stability is defined as: 1. Off IV loop diuretics for ≥ 24 hours without need for reinitiation of IV diuretics. 2. No evidence of pulmonary congestion, defined as both: i) No new or worsening dyspnea at rest compared with status at admission ii) Clear lung auscultation or clinically improved, or normal lung and/or vena cava ultrasound without evidence of congestion. 3. No new or worsening peripheral edema compared with status at admission.
Time frame: From enrollment to 1 month follow-up
Thirst Distress
Thirst Distress Scale for patients with Heart Failure (TDS-HF). Scores range from 8 to 40. Higher scores indicate greater thirst-related distress
Time frame: From enrollment to 1 month follow up
Patient-perceived Quality of Life
Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100, with higher scores indicating better health status.
Time frame: From enrollment to 1 month follow up
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of occurrences during hospitalization of clinical worsening (escalation of HF therapy, such as vasopressor/inotrope initiation, ICU transfer, dialysis, reinitiation of IV diuretics), electrolyte disturbances, worsening renal function, or in-hospital death, and similarly after one month including HF hospitalization
Time frame: From enrollment to 1 month follow up
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