NCT04606927

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 22, 2024

Completed
Last Updated

April 22, 2024

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

October 18, 2020

Results QC Date

November 1, 2023

Last Update Submit

November 1, 2023

Conditions

Heart Failure Acute

Keywords

loop diureticsnatriuresis

Outcome Measures

Primary Outcomes (2)

  • Total Natriuresis After 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).

    24 hours

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

    180 days

Secondary Outcomes (5)

  • 48-hours Natriuresis

    48 hours

  • 72-hours Natriuresis

    72 hours

  • Length of Hospital Stay

    Variable

  • Percentage Change in NT-proBNP at 48 Hours

    48 hours

  • Percentage Change in NT-proBNP at 72 Hours

    72 hours

Other Outcomes (3)

  • Safety Endpoint: Doubling of Serum Creatinine at 24 Hours

    24 hours

  • Safety Endpoint: Doubling of Serum Creatinine at 48 Hours

    48 hours

  • Worsening Heart Failure

    During the index hospitalization (variable)

Study Arms (2)

Natriuresis guided treatment

ACTIVE COMPARATOR
Other: Natriuresis

Standard of care

NO INTERVENTION

Interventions

NatriuresisOTHER

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.

Natriuresis guided treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

  • Ter Maaten JM, Beldhuis IE, van der Meer P, Krikken JA, Postmus D, Coster JE, Nieuwland W, van Veldhuisen DJ, Voors AA, Damman K. Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial. Nat Med. 2023 Oct;29(10):2625-2632. doi: 10.1038/s41591-023-02532-z. Epub 2023 Aug 28.

    PMID: 37640861DERIVED

MeSH Terms

Interventions

Natriuresis

Intervention Hierarchy (Ancestors)

DiuresisUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Results Point of Contact

Title
Dr. Jozine ter Maaten
Organization
University Medical Center Groningen
j.m.ter.maaten@umcg.nl
0503616161

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 18, 2020

First Posted

October 28, 2020

Study Start

February 1, 2021

Primary Completion

May 9, 2023

Study Completion

June 1, 2023

Last Updated

April 22, 2024

Results First Posted

April 22, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)