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NCT Number: NCT07804654

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

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.

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Key information

Conditions

Acute Heart Failure (AHF)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Al-Sultan Abdullah, Universiti Teknologi MARA

Shah Alam, Selangor, 42300, Malaysia

About this study

DESTINaTE-AHF evaluated whether the intensity of upfront intravenous loop diuretic therapy influences early decongestive response when treatment is subsequently guided by objective measures of diuretic response. Urinary sodium concentration and urine output were assessed early after treatment and incorporated into predefined treatment algorithms to identify inadequate response and guide subsequent diuretic therapy during the first 24 hours.

Two natriuresis-guided strategies using different upfront diuretic intensities were evaluated against usual clinician-directed care. This design allowed assessment of whether the initial intensity of loop diuretic therapy influences subsequent natriuretic and diuretic response within a protocolised response-guided approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Malaysian nationality
  • Hospitalised with acute heart failure, either de novo acute heart failure or acute decompensated chronic heart failure
  • Clinical evidence of congestion requiring intravenous loop diuretic therapy, with at least one of the following: peripheral oedema, orthopnoea, paroxysmal nocturnal dyspnoea, pulmonary crepitations, elevated jugular venous pressure, ascites, or congestive hepatomegaly
  • Able to provide informed consent

Exclusion criteria

  • End-stage renal disease requiring chronic dialysis
  • Requirement or anticipated requirement for invasive mechanical ventilation
  • Requirement or anticipated requirement for inotropic or vasopressor support
  • Requirement or anticipated requirement for renal replacement therapy
  • Cardiogenic shock or systolic blood pressure below 100 mmHg
  • Pregnancy or breastfeeding
  • Known hypersensitivity to furosemide

Treatment and study plan

Furosemide - HIGH-dose Natriuresis-Guided Strategy

Drug

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.

Other names: HIGH-dose

Furosemide - LOW-dose Natriuresis-Guided Strategy

Drug

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.

Other names: LOW-dose

Loop Diuretic - Standard of Care

Drug

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.

Other names: Standard of Care

Primary outcomes

  1. 24-Hour Urinary Sodium Excretion

    Time frame: From randomisation to 24 hours

    Total urinary sodium excretion during the first 24 hours after randomisation, calculated from the 24-hour urine collection and expressed in mmol.

  2. 24-Hour Urine Volume

    Time frame: From randomisation to 24 hours

    Total urine volume collected during the first 24 hours after randomisation, expressed in litres.

  3. Change From Baseline in Breathlessness Likert Score at 24 Hours

    Time frame: Baseline and 24 hours after randomisation

    Change in participant-reported breathlessness from baseline to 24 hours, assessed using a 5-point Likert scale. Higher scores indicate greater improvement in breathlessness.

Secondary outcomes

  1. Length of Stay

    Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.

    Duration of the index hospitalisation, calculated from the first day of hospital admission to discharge and expressed in days.

  2. Worsening Renal Function at Discharge

    Time frame: From baseline to hospital discharge, assessed up to 30 days.

    Worsening renal function was defined as a doubling of serum creatinine or a greater than 50% reduction in estimated glomerular filtration rate (eGFR) at hospital discharge compared with baseline.

  3. 30-Day Unplanned Heart Failure Rehospitalisation

    Time frame: From hospital discharge to 30 days after discharge

    Number of participants with at least one unplanned hospital readmission for heart failure within 30 days after discharge from the index hospitalisation.

  4. All-Cause Mortality Through 30 Days After Hospital Discharge

    Time frame: From randomisation to 30 days after hospital discharge

    Number of participants who died from any cause from randomisation through 30 days after hospital discharge, including deaths occurring during the index hospitalisation.

Other outcomes

  1. Hypotension

    Time frame: From randomisation to 24 hours

    Number of participants who developed hypotension, defined as systolic blood pressure <90 mmHg.

  2. Worsening Renal Function at 24 Hours

    Time frame: Baseline and 24 hours after randomisation

    Number of participants with worsening renal function, defined as either a doubling of serum creatinine or a >50% reduction in estimated glomerular filtration rate (eGFR) from baseline.

  3. Hypokalaemia at 24 Hours

    Time frame: At 24 hours after randomisation

    Number of participants with hypokalaemia, defined as serum potassium ≤3.0 mmol/L.

  4. Hyponatraemia at 24 Hours

    Time frame: At 24 hours after randomisation

    Number of participants with hyponatraemia, defined as serum sodium ≤120 mmol/L.

  5. Acute Gout Attack

    Time frame: From randomisation to 24 hours

    Number of participants who developed an acute gout attack, defined as an episode of acute inflammatory arthritis clinically diagnosed as gout by the treating physician and/or treated with gout-specific therapy.

Sponsors and collaborators

Lead sponsor

Universiti Teknologi Mara

Other

Registry information

Official study title

Protocolised Decongestive Strategies With Natriuretic Guidance in Acute Heart Failure - Results of The 'DESTINaTE-AHF' Pilot Randomised Controlled Trial

Acronym: DESTINaTE-AHF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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