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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
myocardial function after surgery
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams UniversityRecruiting
  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group sacubitril: (study group)

Group dapagliflozin: (control group):

Arm Description

This group includes (15) patients who will have 200 mg twice daily oral (5) sacubitril-valsartan 1 month before the operation.

This group includes (15) patients who will have a 10 mg single oral dose (4) 1 month before the operation.

Outcomes

Primary Outcome Measures

heart rate
heart rate in beat per minute
Ejection fraction (EF)
myocardial function using transthoracic echo
blood pressure
mean arterial blood pressure

Secondary Outcome Measures

inotropic drugs
total dose of inotropic drugs

Full Information

First Posted
October 9, 2023
Last Updated
October 13, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06090487
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group sacubitril: (study group)
Arm Type
Other
Arm Description
This group includes (15) patients who will have 200 mg twice daily oral (5) sacubitril-valsartan 1 month before the operation.
Arm Title
Group dapagliflozin: (control group):
Arm Type
Other
Arm Description
This group includes (15) patients who will have a 10 mg single oral dose (4) 1 month before the operation.
Intervention Type
Diagnostic Test
Intervention Name(s)
myocardial function after surgery
Intervention Description
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 Outcome Measure Information:
Title
heart rate
Description
heart rate in beat per minute
Time Frame
baseline just after the surgery and every 2 hours for 24 hours post operatively
Title
Ejection fraction (EF)
Description
myocardial function using transthoracic echo
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
Title
blood pressure
Description
mean arterial blood pressure
Time Frame
baseline just after the surgery then every 2 hours for 24 hours post operatively
Secondary Outcome Measure Information:
Title
inotropic drugs
Description
total dose of inotropic drugs
Time Frame
after addmitting to the intensive care just after surgery for the 1st 24 hours post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ain S university
Phone
00201005013194
Email
dramrgaber7@gamil.com
First Name & Middle Initial & Last Name or Official Title & Degree
ain S university
Phone
00201223861535
Email
dr.ahmedelshaf3ey@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amr gaber, lecturer
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ain S university
Phone
01005013194
Email
dramrgaber7@gmail.com
First Name & Middle Initial & Last Name & Degree
ain S university
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amr gaber, lecturer
Phone
01005013194
Email
dramrgaber7@gmail.com

12. IPD Sharing Statement

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

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