Natriuresis-Guided Diuretic Therapy in Patients With Acute Heart Failure With Reduced Ejection Fraction and Chronic Kidney Disease
- Conditions
- Acute Heart FailureChronic Kidney Diseases
- Interventions
- Other: diuretic therapy
- Registration Number
- NCT06203236
- Lead Sponsor
- Assiut University
- 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.
- 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 .
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group diuretic therapy Patients with matched age and sex as control group receiving diuretic therapy only. Natriuresis-guided group diuretic therapy Natriuresis-guided therapy group receiving diuretic therapy guided by natriuresis measurements. Natriuresis-guided group Furosemide 20 MG Natriuresis-guided therapy group receiving diuretic therapy guided by natriuresis measurements. Control group Furosemide 20 MG Patients with matched age and sex as control group receiving diuretic therapy only.
- Primary Outcome Measures
Name Time Method Mean total sodium in urine in both groups. 24 hours Duration of the index hospitalization in both groups. 24 hours
- Secondary Outcome Measures
Name Time Method Mean total urine output 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 All-cause mortality or HF rehospitalization in both groups. 90 days