RecruitingNot ApplicableNCT06092437

Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients

TAILOR-AHF: Randomized Trial Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients

Sponsor

Zuyderland Medisch Centrum

Enrollment

556 participants

Start Date

Feb 27, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure Acute

Summary

Acutely decompensated heart failure (ADHF) is highly prevalent and has a high (financial) burden on the health care system. Treatment often consists of the administration of IV decongestive agents. Adequate dosing is difficult due to varying diuretic resistance and inadequate parameters to evaluate the response. Urine sodium is a promising biomarker to evaluate the diuretic response. It is hypothesized that a tailored, urine sodium guided diuretic algorithm will result in faster and more complete decongestion and therefore lead to better survival (in terms of mortality and heart failure events) while being non-inferior in terms of safety (mainly regression of kidney function).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized, algorithm-guided approach to using water pills (diuretics) in patients hospitalized with acute heart failure — when the heart suddenly cannot pump enough blood, causing fluid to build up in the body. The goal is to find the most effective dosing strategy to remove this excess fluid safely. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with heart failure (any type) - You are experiencing symptoms of acute heart failure such as breathlessness, swelling, or fluid on the lungs - Your blood marker for heart failure (NT-proBNP) is elevated (above 300 pg/mL) - You need intravenous (IV) water pills to treat fluid overload **You may NOT be eligible if...** - You have severe kidney failure (dialysis or near-dialysis level) - You are currently enrolled in another heart failure study - You are in cardiogenic shock or need intensive care - You have another clear cause for your symptoms (like a blood clot in the lungs) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUrine sodium guided diuretic algorithm

Loop diuretics are administered intravenously as soon as possible after diagnosis of ADHF and continued 3dd until recompensation. Spot urine sodium is measured 2 hours after administration of the first in-hospital IV diuretic dose and repeated until the target of 100mmol/L is reached in the first 72 hours of admission (after which, UrNa will be measured once daily). When target is not met, the next dosage of loop diuretic is doubled (max 3dd 250mg furosemide) and thereafter, other diuretics (thiazide, MRA) are added. Acetazolamide in the first 72 hours is advised as background therapy in both treatment arms.

OTHERUsual care

Treatment with IV loop diuretics left to the discretion of the treating physician. Acetazolamide in the first 72 hours is advised as background therapy in both treatment arms.