Is Sacubitril-valsartan Superior to Dapagliflozin in Improving Myocardial Function Performance

Heart Failure Clinical Trial

Official title: Is Sacubitril-valsartan Superior to Dapagliflozin in Improving Myocardial Function and Performance in Patients With Ischemic Cardiomyopathy Undergoing Coronary Artery Bypass Grafting Post-operatively in the Intensive Care Unit

Status Recruiting

Clinical Trial Summary

The aim of this study is to assess whether sacubitril-valsartan is more effective than dapagliflozin in improving function, myocardial performance in patients undergoing CABG operation or not

Clinical Trial Description

Coronary revascularization has matured as a field since coronary artery bypass grafting (CABG) was first developed over 50 years ago, with diagnostic and treatment methods have advanced dramatically. CABG remains the standard of care for obstructive coronary artery disease, particularly for patients with multivessel disease or diabetes. (1) Despite significant therapeutic advances, patients with chronic heart failure (HF) remain at high risk for HF progression and death. Sacubitril/valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP) inhibitor (sacubitril) and an angiotensin II (Ang-II) receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang-II. In consequence, its inhibition increases mainly the levels of both, natriuretic peptides (promoting diuresis, natriuresis and vasodilatation) and Ang-II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release). (2) Sacubitril-valsartan has been used selectively in patients undergoing coronary artery bypass grafting (CABG) and ischemic cardiomyopathy due to safety concerns. In a prospective observational study done by Narayan and his colleagues in Patients with Ischemic Cardiomyopathy Undergoing Off-Pump Coronary Artery Bypass Grafting Primary outcome was tolerability and safety profile. Thirty consecutive patients undergoing CABG with EF <40% were included. No mortality or readmissions occurred during 6 months' follow-up. One patient only experienced hypotension requiring discontinuation. Mild elevation in blood urea nitrogen, so Sacubitril-valsartan is well tolerated in patients with reduced EF undergoing CABG and proved its safety and efficacy. (3) Dapagliflozin is a highly potent, reversible and selective sodium-glucose cotransporter-2 inhibitor indicated worldwide for the treatment of type 2 diabetes. In numerous well-designed clinical studies dapagliflozin as monotherapy and combination therapy with other antihyperglycemic agents provided effective glycemic control and reduced bodyweight and blood pressure (BP) across a broad spectrum of patients. Dapagliflozin reduced the rate of cardiovascular (CV) death or hospitalization for heart failure (HF), did not adversely affect major adverse cardiovascular events (MACE) and possibly reduced progression of renal disease in patients with established atherosclerotic CV disease (CVD) or multiple risk factors for CVD. (4) ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT06090487
• Study type: Interventional
• Source: Ain Shams University
• Contact: ain S university
• Phone: 00201005013194
• Email: dramrgaber7@gamil.com
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Completion date: April 1, 2024