ClinicalTrials.Veeva

Menu

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

A

Assiut University

Status and phase

Not yet enrolling
Phase 4

Conditions

Chronic Kidney Diseases
Acute Heart Failure

Treatments

Other: diuretic therapy
Drug: Furosemide 20 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT06203236
Natriuresis-Guided Diuretics

Details and patient eligibility

About

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.

Full 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 .

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups

Natriuresis-guided group
Active Comparator group
Description:
Natriuresis-guided therapy group receiving diuretic therapy guided by natriuresis measurements.
Treatment:
Drug: Furosemide 20 MG
Other: diuretic therapy
Control group
Active Comparator group
Description:
Patients with matched age and sex as control group receiving diuretic therapy only.
Treatment:
Drug: Furosemide 20 MG
Other: diuretic therapy

Trial contacts and locations

0

Loading...

Central trial contact

Hala Hisham Mohammed Hasan, Candidate

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems