NCT07400991

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Aug 2029

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

May 7, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 3, 2026

Last Update Submit

May 4, 2026

Conditions

Acute Heart Failure (AHF)

Keywords

Fluid RestrictionThirst-driven fluid intakeLiberal fluid intakeAcute heart failureTime to clinical stability

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to 1 month follow-up

Secondary Outcomes (3)

  • Thirst Distress

    From enrollment to 1 month follow up

  • Patient-perceived Quality of Life

    From enrollment to 1 month follow up

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

    From enrollment to 1 month follow up

Study Arms (2)

Thirst-driven, liberal fluid intake

EXPERIMENTAL
Behavioral: Thirst-driven, liberal fluid intake

Fluid restriction

ACTIVE COMPARATOR
Behavioral: Fluid restriction strategy

Interventions

Fluid restriction strategyBEHAVIORAL

Fluid restriction of 1.5 L/day

Fluid restriction
Thirst-driven, liberal fluid intakeBEHAVIORAL

Liberal fluid intake driven by thirst without restrictions

Thirst-driven, liberal fluid intake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Gødstrup Hospital

Herning, 7400, Denmark

RECRUITING

Central Study Contacts

Anders Hostrup Larsen, MD, PhD

CONTACT

0045anders.hostrup@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

May 7, 2026

Record last verified: 2026-02

Locations

DK(1)