Natriuresis-Guided Diuretic Therapy in Patients With Acute Heart Failure With Reduced Ejection Fraction and Chronic Kidney Disease

January 10, 2024 updated by: Hala Hisham Mohammed Hasan, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Natriuresis-guided diuretic therapy represents a promising approach in managing the complex and challenging clinical scenario of patients with acute heart failure (AHF) . These patients present a unique set of therapeutic dilemmas as traditional diuretic use to relieve congestion in AHF can potentially exacerbate renal dysfunction in those with preexisting CKD . Natriuresis-guided therapy improve patient centered outcomes by adjusting diuretic treatment based on the measurement of urinary sodium excretion which is feasible and able to improve decongestion in AHF with volume overload .

Patients with both AHF and CKD often experience disrupted fluid dynamics, biochemically, it appears covertly as an abnormality in renal function and when progressive, is manifested by symptom exacerbation and worsening renal impairment during application of therapy to ameliorate such symptoms. The pathways leading to these distinct impairments involve not only hemodynamic deterioration but also neurohormonal, inflammatory, and intrinsic renal mechanisms that produce this syndrome .

Natriuresis-guided diuretic therapy, by focusing on the excretion of sodium in the urine. Natriuresis-guided diuretic therapy assesses sodium excretion in urine, offering a direct way to gauge diuretic effectiveness in managing fluid in heart failure (HF) patients. In HF, neurohormonal activation can cause resistance to loop diuretics, leading to persistent congestion. Urinary sodium (UNa) measurement, recommended by ESC guidelines, helps evaluate diuretic response. Early UNa assessment aligns with observational studies, but controlled trials are ongoing. Traditional metrics like weight loss have limitations. UNa assessment can assist diuretic therapy, but factors like fluid overload severity, timing of assessment, kidney disease, and diuretic type should be considered .

One of the primary advantages of natriuresis-guided therapy is its potential to tailor treatment strategies to individual patient responses. It recognizes that not all patients with AHF and CKD will respond to diuretics in the same way. Natriuretic response measured via the urinary sodium (UNa) concentration in a urine spot sample has gained popularity as a metric used for early assessment of diuretic response. In patients with chronic kidney disease admitted for AHF, assessment of intrinsic renal sodium avidity using a random UNa spot sample provides an opportunity to gain insights into decongestive and diuretic responses to IV diuretic drug administration .

The concept of natriuresis-guided therapy represents a departure from the conventional one-size-fits-all treatment model in acute heart failure (AHF) management. Instead, it aligns with the emerging paradigm of precision medicine, emphasizing that personalized therapeutic decisions should be based on individual patient attributes, notably renal function. This approach holds promise for optimizing diuretic therapy, mitigating the frequency of hospital readmissions, and enhancing the overall quality of life for individuals concurrently experiencing AHF and chronic kidney disease (CKD).

One significant challenge in implementing natriuresis-guided therapy is the need for frequent and accurate measurements of urinary sodium excretion. Urine collection and sodium analysis can be cumbersome and may require specialized equipment .

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Natriuresis-guided group
Natriuresis-guided therapy group receiving diuretic therapy guided by natriuresis measurements.
Drug: Furosemide 20 MG
  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.
Other Names:
  • Lasix 20 MG
Other: diuretic therapy
diuretic therapy
Active Comparator: Control group
Patients with matched age and sex as control group receiving diuretic therapy only.
Drug: Furosemide 20 MG
  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.
Other Names:
  • Lasix 20 MG
Other: diuretic therapy
diuretic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean total sodium in urine in both groups.
Time Frame: 24 hours
24 hours
Duration of the index hospitalization in both groups.
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality or HF rehospitalization in both groups.
Time Frame: 90 days
90 days
Mean total sodium in urine in both groups.
Time Frame: 90 days
90 days
Incidence of arrythmatic complications as AF, VT and incidence of hypokalemia and hypomagnesaemia in both groups.
Time Frame: 90 days
90 days
Mean total urine output in both groups.
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Salah Eldin Sayed Atta, Supervisor, Assiut University
  • Study Director: Heba Mahmoud Abdel-Mohsen El-Naggar, Supervisor, Assiut University
  • Study Director: Mohamed Abdullah Khalifah, Supervisor, South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Natriuresis-Guided Diuretics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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