Restrictive versus liberal fluid intake for patients hospitalized with acute heart failure

Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure: a Randomized Trial

This study will try whether a thirst-driven, liberal drinking plan works as well as a fluid-restriction plan for adults hospitalized with acute decompensated heart failure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gødstrup Hospital (other)
• Locations: 1 site (Herning)
• Trial ID: NCT07400991 on ClinicalTrials.gov

What this trial studies

This interventional trial compares a thirst-driven liberal fluid-intake strategy with a fluid-restriction strategy in adults admitted for acute decompensated heart failure. Participants follow their assigned drinking plan during the hospital stay and for one month after discharge. The study will monitor time to clinical stability, safety outcomes, patient-reported thirst, and quality of life. Key endpoints include clinical stability and adverse events related to fluid management.

Who should consider this trial

Good fit: Adults over 18 years hospitalized for acute decompensated heart failure who receive intravenous loop diuretics (≥40 mg furosemide equivalent) and can be enrolled within 24 hours of admission are the intended participants.

Not a fit: People not hospitalized for acute decompensated heart failure, those requiring individualized fluid limits for other medical reasons, or those unable to consent are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could allow patients to drink according to thirst and reduce distress from thirst while maintaining safe heart-failure outcomes.

How similar studies have performed: Direct randomized comparisons of thirst-driven liberal intake versus strict fluid restriction in hospitalized acute heart failure are limited, so this approach is relatively novel though related fluid-management questions have been explored in smaller or outpatient studies.

Eligibility criteria

Inclusion Criteria:

1. Age \>18 years
2. Hospitalized for ADHF as the primary diagnosis, meeting both of the following:

   1. ≥1 documented symptom of new or worsening heart failure (dyspnea, fatigue, decreased exercise tolerance, or symptom of end-organ hypoperfusion).
   2. 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 \[CVP \>12 mmHg, PCWP \>18 mmHg, CI \<2.2 L/min/m2\]).
3. Treatment with ≥40 mg IV furosemide (or equivalent)
4. Enrolment within 24 hours of admission
5. Ability to provide informed consent

Exclusion Criteria:

1. Requirement at admission for ICU-level care, or IV inotropic/vasopressor therapy for ADHF.
2. Na+ \<125 mmol/L or Na+ \>145 mmol/L.
3. End-stage chronic kidney disease on chronic dialysis or eGFR \<15 mL/min/1.73 m2
4. Any condition which would make participation unsafe or substantially affect protocol adherence, as judged by investigator.

Where this trial is running

Herning

• Department of Cardiology, Gødstrup Hospital — Herning, Denmark (RECRUITING)

Study contacts

• Study coordinator: Anders Hostrup Larsen, MD, PhD

Conditions: Acute Heart Failure, Fluid Restriction, Thirst-driven fluid intake, Liberal fluid intake, Acute heart failure, Time to clinical stability