Restrictive versus liberal fluid intake for patients hospitalized with acute heart failure
Official title: Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure: a Randomized Trial
Run by Gødstrup Hospital · NCT07400991 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Gødstrup Hospital Academic / other |
| Locations | 1 site (Herning) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | May 1, 2029 |
| Study ends | August 2029 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07400991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Department of Cardiology, Gødstrup Hospital
Herning, Denmark Recruiting
Study contacts
- Study coordinator: Anders Hostrup Larsen, MD, PhD
- Email: anders.hostrup@rm.dk
- Phone: 0045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.