Department of Cardiology, Gødstrup Hospital
Herning, 7400, Denmark
Location status: Recruiting
NCT Number: NCT07400991
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Herning, 7400, Denmark
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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]).
Exclusion criteria
Fluid restriction of 1.5 L/day
Liberal fluid intake driven by thirst without restrictions
Time frame: From enrollment to 1 month follow-up
Time from randomization to clinical stability. Clinical stability is defined as:
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Gødstrup Hospital
Other
Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure: a Randomized Trial
Acronym: RELIEF-AHF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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