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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Cardiology, Gødstrup Hospital
RECRUITING
Herning
Contact Information
Primary
Anders Hostrup Larsen, MD, PhD
anders.hostrup@rm.dk
0045
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2029-08
Participants
Target number of participants: 420
Treatments
Experimental: Thirst-driven, liberal fluid intake
Active_comparator: Fluid restriction
Related Therapeutic Areas
Sponsors
Leads: Gødstrup Hospital

This content was sourced from clinicaltrials.gov