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Completed

NCT Number: NCT06090487

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

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

Completed

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

myocardial function after surgery

Diagnostic Test

This group includes (15) patients who will have 200 mg twice daily oral (5) sacubitril-valsartan 1 month before the operation. transthoracic echo will be done before and after surgery, also total dose if inoptropic drugs will be noted

Primary outcomes

  1. heart rate

    Time frame: baseline just after the surgery and every 2 hours for 24 hours post operatively

    heart rate in beat per minute

  2. Ejection fraction (EF)

    Time frame: 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

    myocardial function using transthoracic echo

  3. blood pressure

    Time frame: baseline just after the surgery then every 2 hours for 24 hours post operatively

    mean arterial blood pressure

Secondary outcomes

  1. inotropic drugs

    Time frame: after addmitting to the intensive care just after surgery for the 1st 24 hours post operatively

    total dose of inotropic drugs

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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