Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients W… (NCT07023016) | Clinical Trial Compass
CompletedPhase 2/3
Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure
Egypt515 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) prior to inclusion.
* 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 synd…
What they're measuring
1
Difference in mean eGFR (mL/min/1.73m2) between both groups at 12 weeks post-randomization.