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Completed NCT07023016

Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure

Conditions: Acute Decompensated Heart Failure (ADHF), Chronic Kidney Disease (CKD)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 515
Sponsor: National Heart Institute, Egypt

Location: Cairo University Hospitals Cairo

Summary

Sacubitril/valsartan is an established medication for heart failure. However, data still lags in its use in heart failure patients with chronic kidney disease. Sacubitril/valsartan is manufacturer-labeled for use in patients with eGFR \< 30 ml/min/1.73 m2 at an initial dose of 24/26mg twice daily. However, to the best of our knowledge, the concept of sacubitril/valsartan or ACEi in patients with chronic kidney disease \& presenting with decompensated heart failure has not yet been explored fully.

Eligibility Criteria

Inclusion Criteria: All the following should be met: * Acute decompensated heart failure (ADHF) * Left ventricular ejection fraction (LVEF) below 40% * Renal dysfunction; defined as eGFR of 30mL/min/1.73m2 to less than 60mL/min/1.73m2 in relation to the level of urinary albumin/creatinine ratio (uACR) based on the 2024 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines for the evaluation and management of CKD. * A minimum blood pressure (BP) ≥ 105/60 mmHg. * Independent of any inotropic or vasopressor support in the previous 24 hours before inclusion and randomization. * No more than 72 hours had passed since admission to the heart failure unit. * Patients should have had a New York Heart Association (NYHA) functional class II-IV, in addition to symptoms of volume overload at the time of presentation to the emergency room. Exclusion Criteria: * Patients who were on sacubitril/valsartan or ACEI/ angiotensin receptor blocker (ARB) before inclusion in the previous 12 months. * Patients with AKI on presentation OR in the last 3 months OR had ≥ 2 hospital admissions in the last 12 months for AKI. * History of known or suspected hypersensitivity, contraindications, or intolerance to any of the study drugs including ACEI, ARB or sacubitril (neprilysin inhibitor). * Requirement for double treatment with both ACEI and ARB. * Serum potassium (K+) level ≥ 5.0 mmol/L at randomization. * A recent major adverse cardiovascular/cerebrovascular event within 1 month (acute coronary syndrome, stroke, transient ischemic attack, etc.). * Patients with hemodynamically significant primary valvular lesion. * Known hepatic impairment with a model for end-stage liver disease (MELD) score \>10. 23 * History of malignancy of any organ system within the past year with a life expectancy \< 1 year.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07023016). StuddyBuddy aggregates publicly available trial information.