Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients

NCT06092437 | Recruiting

• 1 other identifier: Z2021110
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 2

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).

Conditions

Heart Failure Acute

Keywords

Decongestion; Heart failure; Natriuresis; Urinary Sodium

Outcome Measures

Primary Outcomes (1)

• Hierarchical composite of all-cause mortality, heart failure events and delta quality of life at 90 days follow-up.

  The primary endpoint is a hierarchical composite calculated using a win-ratio approach of: i) Mortality (all-cause) at 90 days after hospitalization; ii) Heart failure events at 90 days after hospitalization (1. a \>2 times increase in oral loop diuretic dose, 2. the need for iv administration of loop diuretics, 3. an emergency department visit or hospitalization for HF), wherein a single event or hospitalization will be sufficient to reach the combined endpoint; iii) Delta in quality of life measured using the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) from baseline to 90 days after hospitalization

  90 days after inclusion

Secondary Outcomes (15)

• Delta NT-pro BNP

  From admission to discharge and 90 days after hospitalisation

• Successful decongestion

  Day 3 after inclusion

• Change in clinical congestion score

  From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days),

• Quality of life (Kansas City Cardiomyopathy Questionnaire)

  90 days after inclusion

• Adverse (safety) events

  90 days after inclusion

Study Arms (2)

Tailored, Urine sodium guided, intensified diuretic strategy

EXPERIMENTAL

Other: Urine sodium guided diuretic algorithm

Usual care

ACTIVE COMPARATOR

Other: Usual care

Interventions

Urine sodium guided diuretic algorithm OTHER

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.

Tailored, Urine sodium guided, intensified diuretic strategy

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (2)

Zuyderland MC

Heerlen, Limburg, 6419 PC, Netherlands

RECRUITING

Amphia ziekenhuis

Breda, North Brabant, 4818 CK, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Sandra van Wijk, MD, PhD

CONTACT

088 - 459 9701; s.vanwijk@zuyderland.nl

Mick Hoen, MD

CONTACT

088 - 459 9701; m.hoen@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: October 23, 2023
• Study Start: February 27, 2023
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): August 27, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)