Rationale and design of the ADVOR (Acetazolamide in Decompensated Heart Failure with Volume Overload) trial.
Wilfried Mullens, Frederik H Verbrugge, Petra Nijst...
https://pubmed.ncbi.nlm.nih.gov/30238574Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06535529
Acetazolamide Versus Dapagliflozin in Adult Patients with Acute Decompensated Heart Failure
Led by Helwan University · Updated on 2024-08-05
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effects of acetazolamide versus dapagliflozin when added to standard intravenous loop diuretics in adults with acute decompensated heart failure (ADHF) who show clinical signs of volume overload. This study aims to determine which drug better reduces N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and improves loop diuretic efficiency, helping to clear excess fluid from the body. The study is a prospective, randomized trial involving adult patients admitted with ADHF and confirmed heart failure by echocardiography. Participants are randomly assigned to receive either oral acetazolamide 500 mg once daily or oral dapagliflozin 10 mg once daily for three days, alongside intravenous loop diuretics given at double the oral maintenance dose. The loop diuretics are administered as a single bolus immediately after randomization, followed by two or more divided doses over the next two days. Treatment adherence and effects are assessed using the modified ADVOR congestion score, which evaluates edema, pleural effusion, and ascites. Throughout the study, participants will have regular assessments of heart failure symptoms, body weight, laboratory tests, and imaging to evaluate heart function. Researchers will monitor outcomes including changes in NT-proBNP levels, weight loss related to diuretic use, hospital stay duration, mortality within 30 days, and kidney function. Follow-up continues until hospital discharge and for 30 days after starting treatment, ensuring comprehensive safety and effectiveness data collection.
CONDITIONS
Brief Title
Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Hospital admission with decompensated heart failure and at least one clinical sign of volume overload such as edema, ascites confirmed by echography, or pleural effusion confirmed by chest X-ray or echography
- Left ventricular ejection fraction assessed by imaging within 12 months prior to inclusion
You will not qualify if you...
- Current maintenance therapy with acetazolamide
- Use of SGLT2 inhibitors within 48 hours before randomization
- Estimated glomerular filtration rate (eGFR) less than 20 mL/min/1.73 m2
- Use of non-protocol diuretics except mineralocorticoid receptor antagonists during the treatment phase; thiazides, metolazone, indapamide, and amiloride must be stopped at study inclusion
- If taking combination drugs including thiazide-type diuretics, the thiazide component must be stopped upon inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 days
Participants receive intravenous loop diuretics and either oral acetazolamide or dapagliflozin once daily as add-on therapy for acute decompensated heart failure.
Multiple visits during treatment for medication administration and monitoring
Follow-up
Duration - Up to 30 days
Participants are monitored for treatment outcomes, including heart failure markers and renal function, up to 30 days after treatment initiation.
Visits as needed for outcome assessments and safety monitoring
Trial Site Locations
Total: 1 location
1
Critical Care Medicine Department - Cairo University Hospitals.
Cairo, Egypt
Actively Recruiting
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Research Team
N
Nouran Mo Anwar, Bachelor
M
Mahmoud I Mostafa, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Acetazolamide in Acute Decompensated Heart Failure with Volume Overload.
Wilfried Mullens, Jeroen Dauw, Pieter Martens...
https://pubmed.ncbi.nlm.nih.gov/36027559Great debate: in patients with decompensated heart failure, acetazolamide in addition to loop diuretics is the first choice.
Wilfried Mullens, Paul Christian Schulze, Julian Westphal...
https://pubmed.ncbi.nlm.nih.gov/37207453Effect of Acetazolamide as Add-On Diuretic Therapy in Patients With Heart Failure: A Meta-Analysis.
Bilal Aziz Malik, Ijeoma Nnodebe, Azrung Fayaz...
https://pubmed.ncbi.nlm.nih.gov/37213994Unlocking the Potential of Acetazolamide: A Literature Review of an Adjunctive Approach in Heart Failure Management.
Michael Sabina, Zein Barakat, Adrian Feliciano...
https://pubmed.ncbi.nlm.nih.gov/38202295Diuretic, natriuretic, and chloride-regaining effects of oral acetazolamide as an add-on therapy for acute heart failure with volume overload: a single-center, prospective, randomized study.
Aneta Kosiorek, Szymon Urban, Jerzy Detyna...
https://pubmed.ncbi.nlm.nih.gov/37415505Acetazolamide as an Adjunctive Diuretic Therapy for Patients with Acute Decompensated Heart Failure: A Systematic Review and Meta-Analysis.
Ahmed Kamal Siddiqi, Muhammad Talha Maniya, Muhammad Tanveer Alam...
https://pubmed.ncbi.nlm.nih.gov/38416359Efficacy and Safety of Dapagliflozin in Patients With Acute Heart Failure.
Zachary L Cox, Sean P Collins, Gabriel A Hernandez...
https://pubmed.ncbi.nlm.nih.gov/38569758