Clinical trial NCT06090487: Is Sacubitril-valsartan Superior to Dapagliflozin in Improving Myocardial Function Performance
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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)

Eligibility criteria: Inclusion Criteria:

1. Age between 50 to 70 years old
2. DM type 2
3. ASA 3
4. Only 2 coronary grafts
5. Elective surgery
6. Bypass time less than 1 hour
7. Senior staff cardiothoracic

Exclusion Criteria:

1. ASA 4 or more
2. Emergency surgery
3. Bypass time of more than 1 hour
4. Coronary grafts of more than 2
5. Any allergy to the used drugs

Primary outcomes:
measure: heart rate
timeFrame: baseline just after the surgery and every 2 hours for 24 hours post operatively
measure: Ejection fraction (EF)
timeFrame: 1.base line before start of medications 2.the day before surgery 3. just after surgery in the intensive care 4. 24 hours after surgery
measure: blood pressure
timeFrame: baseline just after the surgery then every 2 hours for 24 hours post operatively
Secondary outcomes:
measure: inotropic drugs
timeFrame: after addmitting to the intensive care just after surgery for the 1st 24 hours post operatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: amr gaber, lecturer
role: PRINCIPAL_INVESTIGATOR
References: