Clareo Health | Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure
Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Heart Institute, Egypt
With
Cairo University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
