Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07400991

Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Gødstrup Hospital

Herning, 7400, Denmark

Location status: Recruiting

Location contact

Anders Hostrup Larsen, MD, PhD

CONTACT

[email protected]

0045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluid restriction strategy

Behavioral

Fluid restriction of 1.5 L/day

Thirst-driven, liberal fluid intake

Behavioral

Liberal fluid intake driven by thirst without restrictions

Primary outcomes

  1. Time to clinical stability

    Time frame: From enrollment to 1 month follow-up

    Time from randomization to clinical stability. Clinical stability is defined as:

    • Off IV loop diuretics for ≥ 24 hours without need for reinitiation of IV diuretics.
    • 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.

    • No new or worsening peripheral edema compared with status at admission.

Secondary outcomes

  1. Thirst Distress

    Time frame: From enrollment to 1 month follow up

    Thirst Distress Scale for patients with Heart Failure (TDS-HF). Scores range from 8 to 40. Higher scores indicate greater thirst-related distress

  2. Patient-perceived Quality of Life

    Time frame: From enrollment to 1 month follow up

    Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100, with higher scores indicating better health status.

  3. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: From enrollment to 1 month follow up

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Anders Hostrup Larsen, MD, PhD

CONTACT

[email protected]

0045

Sponsors and collaborators

Lead sponsor

Gødstrup Hospital

Other

Registry information

Official study title

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

Acronym: RELIEF-AHF

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 10, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.