Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06092437

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

Led by Zuyderland Medisch Centrum · Updated on 2026-04-13

556

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acutely decompensated heart failure (ADHF) is a common and serious condition that places a heavy financial and health burden on the healthcare system. This research aims to evaluate whether using urine sodium levels to guide diuretic treatment can improve patient outcomes compared to usual care. The study focuses on whether this tailored approach can lead to faster and more complete removal of excess fluid, potentially improving survival and reducing heart failure events, while maintaining safety especially regarding kidney function. Participants are randomly assigned to one of two groups: one group receives a tailored, urine sodium guided intensified diuretic treatment, where intravenous loop diuretics are adjusted based on urine sodium measurements during the first 72 hours of admission; the other group receives usual care with diuretic treatment decided by their physician. Both groups are advised to receive acetazolamide in the first 72 hours. Diuretics are given intravenously soon after diagnosis and continued three times daily until recompensation. During the study, participants are monitored for a variety of outcomes including death, heart failure events, and changes in quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Other assessments include NT-proBNP levels, clinical congestion scores, weight changes, and kidney function over a 90-day follow-up period. Hospital stays, outpatient visits, and adverse events are also tracked. The study uses a double-blinded, randomized design with a primary outcome measured 90 days after inclusion.

CONDITIONS

Brief Title

Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Heart failure diagnosed according to the 2021 European Society of Cardiology guidelines (including HFrEF, HFmrEF, or HFpEF)
  • Presentation with acute heart failure symptoms such as dyspnea, orthopnea, or edema and signs like rales, peripheral edema, ascites, or pulmonary congestion on chest X-ray
  • Elevated NT-proBNP level above 300 pg/ml
  • Need for intravenous diuretic treatment
Not Eligible

You will not qualify if you...

  • Terminal kidney failure defined as dialysis patients or estimated glomerular filtration rate (eGFR) less than 10 mL/min/1.73 m2
  • Participation in other investigational heart failure studies
  • Admission with cardiogenic shock, respiratory failure, or other reasons requiring intensive care unit admission at the time of hospitalization (later ICU transfer during stay is allowed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 days during hospitalization

Participants receive either a tailored urine sodium guided intensified diuretic algorithm or usual care for acute heart failure during their hospital stay to manage symptoms and improve outcomes.

Daily assessments during hospitalization

Follow-up

Duration - 90 days

Participants are monitored for safety, heart failure events, quality of life, and other health outcomes for 90 days after treatment.

Regular visits and assessments up to 90 days after inclusion

Trial Site Locations

Total: 2 locations

1

Zuyderland MC

Heerlen, Limburg, Netherlands, 6419 PC

Actively Recruiting

2

Amphia ziekenhuis

Breda, North Brabant, Netherlands, 4818 CK

Actively Recruiting

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Research Team

S

Sandra van Wijk, MD, PhD

M

Mick Hoen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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