Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluid restriction strategy, Thirst-driven, liberal fluid intake.
- Who it may be relevant to
- Registry conditions: Acute Heart Failure (AHF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure: a Randomized Trial
Overview
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.
Interventions
- Behavioral Fluid restriction strategy
Fluid restriction of 1.5 L/day - Behavioral Thirst-driven, liberal fluid intake
Liberal fluid intake driven by thirst without restrictions
Primary outcome measures
- Time to clinical stability [Time frame: From enrollment to 1 month follow-up]
Secondary outcome measures (3)
- Thirst Distress [Time frame: From enrollment to 1 month follow up]
- Patient-perceived Quality of Life [Time frame: From enrollment to 1 month follow up]
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [Time frame: From enrollment to 1 month follow up]
Eligibility criteria
Inclusion criteria
- Age >18 years
- Hospitalized for ADHF as the primary diagnosis, meeting both of the following:
- ≥1 documented symptom of new or worsening heart failure (dyspnea, fatigue, decreased exercise tolerance, or symptom of end-organ hypoperfusion).
- Objective evidence of ADHF, defined as either:
i. ≥2 physical signs (edema, ascites, pulmonary rales/crackles, increased JVP, S3 gallop, rapid weight gain due to fluid retention), OR ii. ≥1 physical sign AND ≥1 laboratory finding indicative of ADHF (BNP >500 ng/L or NT-proBNP >2000 ng/L if sinus rhythm, or BNP >750 ng/L or NT-proBNP >3000 ng/L if atrial fibrillation, radiological/ultrasound evidence of pulmonary congestion, echocardiographic sign \[VCI >2.1 cm, LVOT VTI <15 cm, E/e' >14, D-dominant pulmonary venous inflow pattern\], or invasive evidence \[CVP >12 mmHg, PCWP >18 mmHg, CI <2.2 L/min/m2\]).
- Treatment with ≥40 mg IV furosemide (or equivalent)
- Enrolment within 24 hours of admission
- Ability to provide informed consent
Exclusion criteria
- Requirement at admission for ICU-level care, or IV inotropic/vasopressor therapy for ADHF.
- Na+ <125 mmol/L or Na+ >145 mmol/L.
- End-stage chronic kidney disease on chronic dialysis or eGFR <15 mL/min/1.73 m2
- Any condition which would make participation unsafe or substantially affect protocol adherence, as judged by investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Cardiology, Gødstrup Hospital — Herning
Identifiers
NCT: NCT07400991 · 1-16-02-56-26