Tailored diuretic treatment for patients with acute heart failure
TAILOR-AHF: Randomized Trial Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients
This study tests if a personalized diuretic treatment based on urine sodium levels can help people with acute heart failure feel better faster than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 556 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Locations | 2 sites (Heerlen, Limburg and 1 other locations) |
| Trial ID | NCT06092437 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a tailored diuretic algorithm based on urinary sodium levels in patients with acutely decompensated heart failure. The study aims to determine if this personalized approach can lead to faster and more complete decongestion compared to standard care, ultimately improving patient outcomes. Participants will be randomly assigned to receive either the tailored treatment or usual care, with their responses monitored to assess effectiveness and safety. The trial is designed to provide evidence for implementing urinary sodium as a biomarker in diuretic therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with acutely decompensated heart failure requiring intravenous diuretics.
Not a fit: Patients with terminal renal insufficiency or those requiring intensive care upon admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced heart failure events for patients with acute heart failure.
How similar studies have performed: While the use of urinary sodium as a biomarker is promising, this specific tailored approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years; * HF (HFrEF, HFmrEF or HFpEF) diagnosed according to the 2021 HF Guidelines of the European Society of Cardiology \[5\]; * Presentation with AHF meaning at least one symptom (dyspnea, orthopnea, or edema) and one sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) of AHF; * An elevated NT-proBNP \>300pg/ml; * Requiring the need for iv diuretics. Exclusion Criteria: * Terminal renal insufficiency defined as: dialysis patients or eGFR (estimated glomerular filtration rate) \< 10 mL/min/1.73 m2; * Patients included in other investigational studies regarding heart failure. * Presentation with cardiogenic shock or respiratory insufficiency or another reason requiring admission to the intensive care unit upon admission (IC transfer later in the hospitalization is not an exclusion).
Where this trial is running
Heerlen, Limburg and 1 other locations
- Zuyderland MC — Heerlen, Limburg, Netherlands (Recruiting)
- Amphia ziekenhuis — Breda, North Brabant, Netherlands (Recruiting)
Study contacts
- Study coordinator: Sandra van Wijk, MD, PhD
- Email: s.vanwijk@zuyderland.nl
- Phone: 088 - 459 9701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.