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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thirst-driven, liberal fluid intake | Experimental |
| |
| Fluid restriction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid restriction strategy | Behavioral | Fluid restriction of 1.5 L/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical stability | Time from randomization to clinical stability. Clinical stability is defined as:
| From enrollment to 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Thirst Distress | Thirst Distress Scale for patients with Heart Failure (TDS-HF). Scores range from 8 to 40. Higher scores indicate greater thirst-related distress | From enrollment to 1 month follow up |
| Patient-perceived Quality of Life |
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Inclusion Criteria:
Age >18 years
Hospitalized for ADHF as the primary diagnosis, meeting both of the following:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anders Hostrup Larsen, MD, PhD | Contact | 0045 | anders.hostrup@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Gødstrup Hospital | Recruiting | Herning | 7400 | Denmark |
Due to regulations by Region Committees on Health Research Ethics
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| Thirst-driven, liberal fluid intake |
| Behavioral |
Liberal fluid intake driven by thirst without restrictions |
|
Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100, with higher scores indicating better health status.
| From enrollment to 1 month follow up |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | 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 | From enrollment to 1 month follow up |