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Protocolised Natriuresis-Guided Decongestion at Different Diuretic Intensities in Acute Heart Failure

NCT07804654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2026-09-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn how different doses of a water-removing medicine (diuretic) work in adults admitted to hospital with acute heart failure. It will also assess the safety of these treatment approaches.

The main questions this study aims to answer are:

Does starting with a higher or lower dose of diuretic affect how much sodium and urine the body removes during the first 24 hours? Are there differences in side effects or short-term health outcomes between the treatment approaches?

Researchers will compare two treatment approaches that use urine sodium and urine output to guide diuretic treatment with standard care. Participants will receive intravenous diuretic treatment and have their urine sodium, urine output, symptoms, blood tests, and clinical outcomes assessed.

Conditions

  • Acute Heart Failure (AHF)

Interventions

DRUG

Furosemide - HIGH-dose Natriuresis-Guided Strategy

Intravenous furosemide was administered according to a predefined HIGH-dose natriuresis-guided protocol during the first 24 hours. For participants not receiving chronic loop diuretic therapy, the protocol-defined 24-hour dose was 80 mg. For chronic loop diuretic users, the protocol-defined 24-hour dose was calculated as 2.5 times their total home oral daily furosemide-equivalent dose and administered intravenously in divided doses. Urinary sodium at 2 and 6 hours and urine output at 6 hours were used to guide subsequent dosing according to predefined response criteria.

DRUG

Furosemide - LOW-dose Natriuresis-Guided Strategy

Intravenous furosemide was administered according to a predefined LOW-dose natriuresis-guided protocol during the first 24 hours. For participants not receiving chronic loop diuretic therapy, the protocol-defined 24-hour dose was 60 mg. For chronic loop diuretic users, the protocol-defined 24-hour dose was calculated as 1.5 times their total home oral daily furosemide-equivalent dose and administered intravenously in divided doses. Urinary sodium at 2 and 6 hours and urine output at 6 hours were used to guide subsequent dosing according to predefined response criteria.

DRUG

Loop Diuretic - Standard of Care

Intravenous loop diuretic therapy was administered according to the treating clinician's usual practice. The dose and subsequent adjustment of loop diuretic therapy were determined by the treating clinical team without a protocol-mandated dosing or escalation strategy. Urinary sodium and urine output were assessed at the same study time points as in the natriuresis-guided groups, but no protocol-directed treatment adjustment was mandated based on these measurements.

Sponsors & Collaborators

  • Universiti Teknologi Mara

    lead OTHER

Principal Investigators

  • Nor Afiqah Mohd Sebri, MB BCh BAO · Universiti Teknologi Mara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-07-01
Completion
2026-07-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804654 on ClinicalTrials.gov