NCT06203236

Brief Summary

To investigate the effectiveness and feasibility of natriuresis-guided diuretic therapy as a personalized approach to managing acute heart failure in patients with underlying chronic kidney disease and its effect on short term outcomes.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2024

Status
unknown

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

November 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

November 22, 2023

Last Update Submit

January 10, 2024

Conditions

Acute Heart FailureChronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

  • Mean total sodium in urine in both groups.

    24 hours

  • Duration of the index hospitalization in both groups.

    24 hours

Secondary Outcomes (4)

  • All-cause mortality or HF rehospitalization in both groups.

    90 days

  • Mean total sodium in urine in both groups.

    90 days

  • Incidence of arrythmatic complications as AF, VT and incidence of hypokalemia and hypomagnesaemia in both groups.

    90 days

  • Mean total urine output in both groups.

    90 days

Study Arms (2)

Natriuresis-guided group

ACTIVE COMPARATOR

Natriuresis-guided therapy group receiving diuretic therapy guided by natriuresis measurements.

Drug: Furosemide 20 MGOther: diuretic therapy

Control group

ACTIVE COMPARATOR

Patients with matched age and sex as control group receiving diuretic therapy only.

Drug: Furosemide 20 MGOther: diuretic therapy

Interventions

Furosemide 20 MGDRUG

1. The median daily total dose of intravenous loop diuretic at the start of treatment will be 20 mg of furosemide. 2. Monitoring of urinary sodium excretion (natriuresis) and diuresis will begin 2 hours after treatment initiation.

Also known as: Lasix 20 MG
Control groupNatriuresis-guided group
diuretic therapyOTHER

diuretic therapy

Control groupNatriuresis-guided group

Eligibility Criteria

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

You may qualify if:

  • Patients presenting with acute heart failure (AHF) with reduced ejection fraction either De novo or ADHF.
  • Patients with chronic kidney disease (CKD) stages 1-4.
  • Patients aged 18 years or older.
  • Patients accept to participate in the study.

You may not qualify if:

  • Patients with significant stenotic valvular diseases (MS, AS).
  • Patients with acute coronary syndrome.
  • Patients with acute cardiogenic shock.
  • Patients with dyspnea primarily due to non-cardiac cause (significant COPD).
  • Patients with severe renal impairment requiring dialysis (GFR \< 15 mL/min/1.73 m²).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Testani JM, Hanberg JS, Cheng S, Rao V, Onyebeke C, Laur O, Kula A, Chen M, Wilson FP, Darlington A, Bellumkonda L, Jacoby D, Tang WH, Parikh CR. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circ Heart Fail. 2016 Jan;9(1):e002370. doi: 10.1161/CIRCHEARTFAILURE.115.002370.

    PMID: 26721915BACKGROUND

  • Deferrari G, Cipriani A, La Porta E. Renal dysfunction in cardiovascular diseases and its consequences. J Nephrol. 2021 Feb;34(1):137-153. doi: 10.1007/s40620-020-00842-w. Epub 2020 Sep 1.

    PMID: 32870495BACKGROUND

  • Raina R, Nair N, Chakraborty R, Nemer L, Dasgupta R, Varian K. An Update on the Pathophysiology and Treatment of Cardiorenal Syndrome. Cardiol Res. 2020 Apr;11(2):76-88. doi: 10.14740/cr955. Epub 2020 Mar 10.

    PMID: 32256914BACKGROUND

  • Brown JR, Uber PA, Mehra MR. The progressive cardiorenal syndrome in heart failure: mechanisms and therapeutic insights. Curr Treat Options Cardiovasc Med. 2008 Aug;10(4):342-8. doi: 10.1007/s11936-008-0054-5.

    PMID: 18647589BACKGROUND

  • Oliva-Damaso N, Nunez J, Soler MJ. Spot Urinary Sodium as a Biomarker of Diuretic Response in Acute Heart Failure. J Am Heart Assoc. 2023 Sep 5;12(17):e030044. doi: 10.1161/JAHA.123.030044. Epub 2023 Aug 23. No abstract available.

    PMID: 37609987BACKGROUND

  • Martens P, Chen HH, Verbrugge FH, Testani JT, Mullens W, Tang WHW. Assessing intrinsic renal sodium avidity in acute heart failure: implications in predicting and guiding decongestion. Eur J Heart Fail. 2022 Oct;24(10):1978-1987. doi: 10.1002/ejhf.2662. Epub 2022 Sep 6.

    PMID: 36054180BACKGROUND

  • Meekers E, Mullens W. Spot Urinary Sodium Measurements: the Future Direction of the Treatment and Follow-up of Patients with Heart Failure. Curr Heart Fail Rep. 2023 Feb;20(1):88-100. doi: 10.1007/s11897-023-00591-4. Epub 2023 Feb 21.

    PMID: 36807114BACKGROUND

  • Ter Maaten JM, Beldhuis IE, van der Meer P, Krikken JA, Coster JE, Nieuwland W, van Veldhuisen DJ, Voors AA, Damman K. Natriuresis-guided therapy in acute heart failure: rationale and design of the Pragmatic Urinary Sodium-based treatment algoritHm in Acute Heart Failure (PUSH-AHF) trial. Eur J Heart Fail. 2022 Feb;24(2):385-392. doi: 10.1002/ejhf.2385. Epub 2022 Jan 6.

    PMID: 34791756BACKGROUND

  • 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: 37640861BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Salah Eldin Sayed Atta, Supervisor

    Assiut University

    STUDY CHAIR

  • Heba Mahmoud Abdel-Mohsen El-Naggar, Supervisor

    Assiut University

    STUDY DIRECTOR

  • Mohamed Abdullah Khalifah, Supervisor

    South Valley University

    STUDY DIRECTOR

Central Study Contacts

Hala Hisham Mohammed Hasan, Candidate

CONTACT

+201022337251doctor.hala.hisham@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 22, 2023

First Posted

January 12, 2024

Study Start

January 1, 2024

Primary Completion

March 1, 2025

Study Completion

November 1, 2025

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share