Skip to main content
OpenTrials
Completed

NCT Number: NCT04606927

Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

Administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. Unfortunately, there is a lack of evidence of how to guide diuretic treatment. Recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. The hypothesis of this study is that natriuresis guided therapy in patients with acute heart failure will improve diuretic response, decongestion, and reduce length of hospital stay, as well as heart failure rehospitalisations.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Acute

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

About this study

Objective: To assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes

Study design: Randomised, controlled, open label study

Study population: 310 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.

Intervention: natriuresis guided treatment versus standard of care

Main study parameters/endpoints:

Co-primary outcome: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Secondary outcomes: 48- and 72-hours natriuresis, length of hospital stay, percentage change in NT-proBNP at 48 and 72 hours.

Safety endpoint: doubling of serum creatinine at 24 or 48 hours, worsening heart failure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female ≥ 18 years of age
  • Primary diagnosis of acute /decompensated heart failure as assessed by treating physician

a. Acute Heart failure can be de novo or exacerbation of known heart failure and diagnosis is based on criteria in the ESC HF guidelines

  • Requirement of intravenous diuretic use

Exclusion criteria

  • Dyspnoea primarily due to non-cardiac causes
  • Patients with severe renal impairment receiving dialysis or requiring ultrafiltration
  • Inability to follow instructions
  • Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study

Treatment and study plan

Natriuresis

Other

Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.

Primary outcomes

  1. Total Natriuresis After 24 Hours

    Time frame: 24 hours

    The first component of the co-primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 hours after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).

  2. First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days

    Time frame: 180 days

Secondary outcomes

  1. 48-hours Natriuresis

    Time frame: 48 hours

    48-hour natriuresis will be assessed by collecting urine for a second period of 24 hours after the first 24-hour urine collection according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).

  2. 72-hours Natriuresis

    Time frame: 72 hours

    72-hour natriuresis will be assessed by collecting urine for a third period of 24 hours after the second 24-hour urine collection according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).

  3. Length of Hospital Stay

    Time frame: Variable

    Number of days of the index hospitalization

  4. Percentage Change in NT-proBNP at 48 Hours

    Time frame: 48 hours

    Relative NT-proBNP change (%) after 48 hours compared with baseline

  5. Percentage Change in NT-proBNP at 72 Hours

    Time frame: 72 hours

    Relative NT-proBNP change (%) after 72 hours compared with baseline

Other outcomes

  1. Safety Endpoint: Doubling of Serum Creatinine at 24 Hours

    Time frame: 24 hours

    The first safety endpoint is defined as number of patients with a doubling of serum creatinine at 24 hours compared with baseline serum creatinine.

  2. Safety Endpoint: Doubling of Serum Creatinine at 48 Hours

    Time frame: 48 hours

    The second safety endpoint is defined as the number of patients with a doubling of serum creatinine at 48 hours compared with baseline serum creatinine.

  3. Worsening Heart Failure

    Time frame: During the index hospitalization (variable)

    The third safety endpoint is defined as the number of patients with worsening heart failure during hospitalization.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: PUSH-AHF

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2020
Registry last updated
Apr 22, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.