Acute Decompensated Heart FailurePhase 4COAF-HFNCT06475105
Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure Outcomes
A Phase 4 study testing Oral Acetazolamide in people with Acute Decompensated Heart Failure, run by Universitas Diponegoro at 2 sites in Indonesia.
Trial summary
Based on ADVOR trial, the potential of adding acetazolamide in increasing the success of decongestion, the amount of natriuresis and diuresis. However, the use of intravenous acetazolamide may not be possible in Indonesia, where the intravenous formulation is not available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Oral Acetazolamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesIndonesia
- Study dates
- 20 Apr 2024to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to be included in the research by signing informed consent
- Patients with a clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload with a congestion score ≥2 (ADVOR Score) (e.g. edema (score 2 or more), ascites confirmed by physical examination or ultrasonography or pleural effusion confirmed by chest x-ray or echocardiography).
- Patients on routine oral loop diuretic therapy with a dose of ≥40 mg furosemide for ≥1 month
- Plasma NT-proBNP levels that increase ≥300 pg/mL or the applicable cut-off according to the age range at the time of examination in the ER.
Who cannot join
- Subjects with acute coronary syndrome
- History of congenital heart disease requiring surgical correction.
- Subjects in cardiogenic shock.
- Estimated glomerular filtration rate <20 mL/min/1.73m² at the time of examination.
- Use of renal replacement therapy or ultrafiltration at any time before the study was included.
- Treatment with acetazolamide within 1 month before randomization.
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- Exposure to nephrotoxic agents (i.e. contrast dye) is anticipated within the next 3 days
- Subjects who are pregnant or breastfeeding.
- Subjects with urinary incontinence who are unwilling to use a bladder catheter.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites, 2 recruiting
- Recruiting
Department of Cardiology and Vascular Medicine, Universitas Diponegoro, Kariadi Central General Hospital
Semarang, Central Java, 50244
Inne P Farissa, MD, 024-8413476 ext. 6282, innefarissa@gmail.com
Ilham Uddin, MD
- Recruiting
Kariadi Central General Hospital
Semarang, Central Java, 50244
Inne P Farissa, MD, 024-8413476 ext. 6282, innefarissa@gmail.com
About this study
Official title: Effects of Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure
Based on ADVOR trial, the potential of adding acetazolamide in increasing the success of decongestion, the amount of natriuresis and diuresis. However, the use of intravenous acetazolamide may not be possible in Indonesia, where the intravenous formulation is not available. This clinical research study is being conducted in single hospitals in Indonesia. We aim to learn if Oral Acetazolamide in addition to Furosemide intravenous works to treat congestion in Acute Decompensated Heart Failure, besides evaluating the total urinary output, change of NT pro BNP level, and safety profile of oral Acetazolamide.
The hypothesis of this study is oral acetazolamide works well to achieve successful decongestion.
Read the detailed description
This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with ADHF who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive intravenous furosemide and oral acetazolamide. Patients randomized to the other treatment group will receive a combination of iv furosemide and placebo. It is expected that the patients of the treatment group with the combination therapy will have a faster reduction of their fluid overload. In consequence the treatment duration and total dose of diuretics administered will be shorter.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Oral Acetazolamide, Placebo
- Keywords
- Oral Acetazolamide, Acute Decompensated Heart Failure, Congestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral AcetazolamideDrug
Also called Glauseta
Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days
PlaceboDrug
Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days
| Study group | Role | What they receive |
|---|---|---|
| Group A (Oral Acetazolamide) | Experimental | Participants who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days. Receives: Drug: Oral Acetazolamide |
| Group B (Placebo) | Placebo comparator | Participants who received intravenous furosemide plus Placebo / 12 hours orally for up to 3 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Decongestion
Conditions without volume overload, no signs of excess volume within 3 days of treatment. Congestion was assessed using the volume assessment score (also called congestion score) from the ADVOR trial. The absence of fluid volume excess was defined as no more than mild edema, no residual pleural effusion, and no residual ascites. Total score ≤1 indicates that decongestion has been achieved, score >1 is considered to indicate persistent fluid volume excess (decongestion not achieved).
Measured: within 3 days
Secondary outcomes (4)
NT pro BNP
the effect of adding combination oral acetazolamide on NT pro BNP levels in ADHF participants who received iv furosemide
Measured: within 3 days
Renal Function
Kidney function is measured based on estimated GFR (eGFR) according to the CKD-EPI formula which is shown in units of mL/min/1.73 m2 taken on day 0, day 2, and day 4, every 48 hours during hospitalization (after receiving treatment).
Measured: From date of randomization until the date of first documented worsening renal function (increased of creatinine serum level >50% of baseline creatinine) or date of death from any cause, evaluation every 48 hours or whichever came first, up to 90 days
Urinary Output
the amount of urine for 24 hours is measured from the time the patient arrives at the emergency room, a urinary catheter tube is installed, measured every 24 hours during hospital treatment.
Measured: From date of randomization until participants discharge from hospital up to 7 days post discharge.
Length of Stay
Defined as the duration of the patient receiving treatment in hospital from the time admitted to the ER until the patient was discharged/discharged from the hospital, obtained as the date of discharge from the hospital minus the sampling date +1.
Measured: From date of randomization until the date of first documented progression and discharge from hospital or date of death from any cause, whichever came first, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start20 Apr 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is an experimental clinical study with a double blinded randomized controlled trial design. The study group consisted of patients with acute decompensated heart failure with volume overload who required intravenous diuretic therapy. The first group was patients who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days (group A). Meanwhile, the second group was patients who received intravenous furosemide plus placebo for up to 3 days (group B).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilham Uddin, MD, Universitas Diponegoro
- Investigators
- Ilham Uddin, MD, Principal investigator, Department Cardiology and Vascular Medicine Universitas Diponegoro Kariadi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475105
- Sponsor's protocol ID
- No16129/EC/KEPK-RSDK/2024
- Acronym
- COAF-HF
- Status last verified
- Oct 2024
- First submitted
- 19 Jun 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, the decision regarding which Individual Participant Data (IPD) will be included for sharing is still under consideration. This undecided status is due to several key factors that require thorough evaluation
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06475105
- Acronym / sponsor ID
- COAF-HF / No16129/EC/KEPK-RSDK/2024
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Oral Acetazolamide, Acute Decompensated Heart Failure, Congestion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on ADVOR trial, the potential of adding acetazolamide in increasing the success of decongestion, the amount of natriuresis and diuresis. However, the use of intravenous acetazolamide may not be possible in Indonesia, where the intravenous formulation is not available. This clinical research study is being conducted in single hospitals in Indonesia. We aim to learn if Oral Acetazolamide in addition to Furosemide intravenous works to treat congestion in Acute Decompensated Heart Failure, besides evaluating the total urinary output, change of NT pro BNP level, and safety profile of oral Acetazolamide.
The hypothesis of this study is oral acetazolamide works well to achieve successful decongestion.
Detailed description
This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with ADHF who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive intravenous furosemide and oral acetazolamide. Patients randomized to the other treatment group will receive a combination of iv furosemide and placebo. It is expected that the patients of the treatment group with the combination therapy will have a faster reduction of their fluid overload. In consequence the treatment duration and total dose of diuretics administered will be shorter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This research is an experimental clinical study with a double blinded randomized controlled trial design. The study group consisted of patients with acute decompensated heart failure with volume overload who required intravenous diuretic therapy. The first group was patients who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days (group A). Meanwhile, the second group was patients who received intravenous furosemide plus placebo for up to 3 days (group B).
| Arm | Type | Receives |
|---|---|---|
| Group A (Oral Acetazolamide) | Experimental | Drug: Oral AcetazolamideParticipants who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days. |
| Group B (Placebo) | Placebo comparator | Drug: PlaceboParticipants who received intravenous furosemide plus Placebo / 12 hours orally for up to 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agree to be included in the research by signing informed consent
- Patients with a clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload with a congestion score ≥2 (ADVOR Score) (e.g. edema (score 2 or more), ascites confirmed by physical examination or ultrasonography or pleural effusion confirmed by chest x-ray or echocardiography).
- Patients on routine oral loop diuretic therapy with a dose of ≥40 mg furosemide for ≥1 month
- Plasma NT-proBNP levels that increase ≥300 pg/mL or the applicable cut-off according to the age range at the time of examination in the ER.
Key exclusion criteria (9 listed)
- Subjects with acute coronary syndrome
- History of congenital heart disease requiring surgical correction.
- Subjects in cardiogenic shock.
- Estimated glomerular filtration rate <20 mL/min/1.73m² at the time of examination.
- Use of renal replacement therapy or ultrafiltration at any time before the study was included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral AcetazolamideAlso: GlausetaParticipants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days | Drug | Group A (Oral Acetazolamide) |
| PlaceboParticipants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days | Drug | Group B (Placebo) |
Primary outcome
Successful Decongestion
Time frame: within 3 days
Conditions without volume overload, no signs of excess volume within 3 days of treatment. Congestion was assessed using the volume assessment score (also called congestion score) from the ADVOR trial. The absence of fluid volume excess was defined as no more than mild edema, no residual pleural effusion, and no residual ascites. Total score ≤1 indicates that decongestion has been achieved, score >1 is considered to indicate persistent fluid volume excess (decongestion not achieved).
4 secondary outcomes
NT pro BNP
Time frame: within 3 days
Renal Function
Time frame: From date of randomization until the date of first documented worsening renal function (increased of creatinine serum level >50% of baseline creatinine) or date of death from any cause, evaluation every 48 hours or whichever came first, up to 90 days
Urinary Output
Time frame: From date of randomization until participants discharge from hospital up to 7 days post discharge.
Length of Stay
Time frame: From date of randomization until the date of first documented progression and discharge from hospital or date of death from any cause, whichever came first, assessed up to 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No. Currently, the decision regarding which Individual Participant Data (IPD) will be included for sharing is still under consideration. This undecided status is due to several key factors that require thorough evaluation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilham Uddin, MD principal investigator
Department Cardiology and Vascular Medicine Universitas Diponegoro Kariadi General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Acetazolamide in people with Acute Decompensated Heart Failure, run by Universitas Diponegoro at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inne P Farissa, MD (024-8413476 ext. 6282, innefarissa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Decongestion (time frame: within 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.