NCT06092437 Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients
| NCT ID | NCT06092437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zuyderland Medisch Centrum |
| Condition | Heart Failure Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 556 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2026-06-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 556 participants in total. It began in 2023-02-27 with a primary completion date of 2026-06-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06092437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06092437 currently recruiting?
Yes, NCT06092437 is actively recruiting participants. Contact the research team at s.vanwijk@zuyderland.nl for enrollment information.
Where is the NCT06092437 trial being conducted?
This trial is being conducted at Heerlen, Netherlands, Breda, Netherlands.
Who is sponsoring the NCT06092437 clinical trial?
NCT06092437 is sponsored by Zuyderland Medisch Centrum. The trial plans to enroll 556 participants.
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