Acute Heart Failure (AHF)
Conditions
Keywords
Fluid Restriction, Thirst-driven fluid intake, Liberal fluid intake, Acute heart failure, Time to clinical stability
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.
Interventions
BEHAVIORALFluid restriction strategy
Fluid restriction of 1.5 L/day
BEHAVIORALThirst-driven, liberal fluid intake
Liberal fluid intake driven by thirst without restrictions
Sponsors
Gødstrup Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical stability | From enrollment to 1 month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thirst Distress | 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 |
| Patient-perceived Quality of Life | 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. |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | 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 |
Countries
Denmark
Contacts
CONTACTAnders Hostrup Larsen, MD, PhD
Outcome results
None listed