Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535529
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-29
Brief Title:
Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the effectiveness of acetazolamide versus dapagliflozin as an add-on in treating acute decompensated heart failure ADHF in adult patients with clinical signs of volume overload requiring intravenous loop diuretics It will also assess the safety of these drugs when added to standard care The main questions it aims to answer are
Does acetazolamide or dapagliflozin lead to a greater reduction in N-terminal pro-B-type natriuretic peptide NT-proBNP levels
Which drug results in better loop diuretic efficiency as measured by weight loss per 40 mg of intravenous furosemide or equivalent We will compare acetazolamide to dapagliflozin both added to standard intravenous loop diuretic therapy to see which is more effective in decongesting patients with ADHF
Participants will
Take either acetazolamide or dapagliflozin orally every day for 3 days
Receive intravenous loop diuretics as part of standard care
Undergo regular assessments of heart failure symptoms weight and laboratory tests
Be followed up until hospital discharge and for 30 days after starting the study
Does acetazolamide or dapagliflozin lead to a greater reduction in N-terminal pro-B-type natriuretic peptide NT-proBNP levels
Which drug results in better loop diuretic efficiency as measured by weight loss per 40 mg of intravenous furosemide or equivalent We will compare acetazolamide to dapagliflozin both added to standard intravenous loop diuretic therapy to see which is more effective in decongesting patients with ADHF
Participants will
Take either acetazolamide or dapagliflozin orally every day for 3 days
Receive intravenous loop diuretics as part of standard care
Undergo regular assessments of heart failure symptoms weight and laboratory tests
Be followed up until hospital discharge and for 30 days after starting the study
Detailed Description:
A Study design
Prospective open-label randomized two-armed parallel comparator study
Participants recruited in the study must provide written informed consent after obtaining ethical approval from ethics committee
B Study settings Critical Care Medicine Department - Cairo University Hospitals C Population of study Adult patients who are admitted to Critical Care Medicine Department - Cairo University Hospitals because of acute decompensated heart failure will be screened for inclusion into the study Patients who have at least one clinical sign of volume overload ie edema pleural effusion or ascites and ECHO-confirmed HF at screening will be included in the study
DTreatment
IV loop diuretics
At the moment of randomization oral loop diuretics are stopped Patients need to empty their bladder before administration of the first dose of loop diuretics and all will receive an intravenous loop diuretic at double the oral maintenance dose administered as a single bolus immediately after randomization and split into more than two doses separated by 6 hours on each of the next 2 days
Group 1 Oral Acetazolamide Together with the initial bolus dose of loop diuretics patients will receive 500 mg oral Acetazolamide Time of subsequent dose of acetazolamide taken once daily will start together with the first maintenance loop diuretic dose
Group 2 Oral Dapagliflozin Together with the initial dose of loop diuretics patients will receive 10 mg Dapagliflozin
Time of subsequent dose of Dapagliflozin taken once daily will start together with the first maintenance loop diuretic dose
E Study tools
Modified ADVOR Score The modified ADVOR congestion score will be calculated on a scale from 0 to 10 based on the sum of scores for the degree of edema 0 to 4 pleural effusion 0 to 3 and ascites 0 to 3 with higher scores indicating a worse condition on all scales This score will be calculated for each included patient before the administration of the first dose of diuretics during the treatment phase at the end of the study
Prospective open-label randomized two-armed parallel comparator study
Participants recruited in the study must provide written informed consent after obtaining ethical approval from ethics committee
B Study settings Critical Care Medicine Department - Cairo University Hospitals C Population of study Adult patients who are admitted to Critical Care Medicine Department - Cairo University Hospitals because of acute decompensated heart failure will be screened for inclusion into the study Patients who have at least one clinical sign of volume overload ie edema pleural effusion or ascites and ECHO-confirmed HF at screening will be included in the study
DTreatment
IV loop diuretics
At the moment of randomization oral loop diuretics are stopped Patients need to empty their bladder before administration of the first dose of loop diuretics and all will receive an intravenous loop diuretic at double the oral maintenance dose administered as a single bolus immediately after randomization and split into more than two doses separated by 6 hours on each of the next 2 days
Group 1 Oral Acetazolamide Together with the initial bolus dose of loop diuretics patients will receive 500 mg oral Acetazolamide Time of subsequent dose of acetazolamide taken once daily will start together with the first maintenance loop diuretic dose
Group 2 Oral Dapagliflozin Together with the initial dose of loop diuretics patients will receive 10 mg Dapagliflozin
Time of subsequent dose of Dapagliflozin taken once daily will start together with the first maintenance loop diuretic dose
E Study tools
Modified ADVOR Score The modified ADVOR congestion score will be calculated on a scale from 0 to 10 based on the sum of scores for the degree of edema 0 to 4 pleural effusion 0 to 3 and ascites 0 to 3 with higher scores indicating a worse condition on all scales This score will be calculated for each included patient before the administration of the first dose of diuretics during the treatment phase at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None