Is Sacubitril-valsartan Superior to Dapagliflozin in Improving Myocardial Function Performance
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Feb 2024
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedSeptember 5, 2024
October 1, 2023
29 days
October 9, 2023
September 1, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
heart rate
heart rate in beat per minute
baseline just after the surgery and every 2 hours for 24 hours post operatively
Ejection fraction (EF)
myocardial function using transthoracic echo
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
blood pressure
mean arterial blood pressure
baseline just after the surgery then every 2 hours for 24 hours post operatively
Secondary Outcomes (1)
inotropic drugs
after addmitting to the intensive care just after surgery for the 1st 24 hours post operatively
Study Arms (2)
Group sacubitril: (study group)
OTHERThis group includes (15) patients who will have 200 mg twice daily oral (5) sacubitril-valsartan 1 month before the operation.
Group dapagliflozin: (control group):
OTHERThis group includes (15) patients who will have a 10 mg single oral dose (4) 1 month before the operation.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
amr gaber, lecturer
Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer clinical doctor
Study Record Dates
First Submitted
October 9, 2023
First Posted
October 19, 2023
Study Start
February 1, 2024
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
September 5, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share