Heart FailurePhase 3NCT05940220
Efficacy of Oral Acetazolamide in Decongestion in Patients With Heart Failure
A Phase 3 study testing Acetazolamide in people with Heart Failure, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
This is a 1:1 ratio single-center, double-blind, randomized controlled trial, aiming to enroll 130 patients admitted in infusion ward. The participants receive furosemide as standard treatment and will randomize towards 250 mg oral acetazolamide twice a day versus placebo on three consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- 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
- 130 participants
- Where
- 1 siteIran
- Study dates
- 30 Dec 2023to 10 Oct 2025
- Phase
- Phase 3
- 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
- Earn at least 8 points from EVEREST score (see Table 1.)
- Adult patients (≥ 18 years)
- A major clinical sign of volume overload including edema, ascites confirmed by abdominal ultrasound, or pleural effusion confirmed by chest x-ray or chest ultrasound without using iv furosemide.
- Maintenance treatment with oral furosemide as a loop diuretic ≥20 mg for at least one month
- Using SGLT2i drugs including canagliflozin, dapagliflozin, and empagliflozin for at least one month
Who cannot join
- Systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg
- Estimated glomerular filtration rate (eGFR) <20 ml/min/1.73 m2
- Using any diuretic agent except mineralocorticoid receptor antagonists including spironolactone and eplerenone
- Simultaneous diagnosis of acute coronary syndrome, which is characterized by typical chest pain in addition to an increase in troponin level above the 99th percentile or electrocardiographic changes indicating ischemia or hospitalization as unstable angina.
Trial locations and contacts
1 site in 1 country.
Houshang bavandpour karvane, resident of cardiology contact
Iran1 site
Houshang bavandpour karvane
Tehran, Tehran Heart Center, 1416753955
Houshang bavandpour karvane, Houshang.bavandpour20@gmail.com
About this study
Official title: Efficacy of Oral Acetazolamide as Add-on Diuretic Therapy in Decongestion in Patients With Heart Failure and Diuretic Resistance
This is a 1:1 ratio single-center, double-blind, randomized controlled trial, aiming to enroll 130 patients admitted in infusion ward. The participants receive furosemide as standard treatment and will randomize towards 250 mg oral acetazolamide twice a day versus placebo on three consecutive days. The main objective is to determine the effect of oral acetazolamide and furosemide combination therapy on the decongestion. Prespecified secondary objectives included N-terminal pro B-type natriuretic peptide level on the 30th day, the readmission rate in a three-month period, quality of life assessment by Heart Failure Quality of Life Questionnaire at the end of the third month, change in weight, creatinine level, urinary sodium excretion, potassium level, and hematological indices in complete blood count at third day of the trial.
Read the detailed description
This is a 1:1 ratio single center, double-blind, RCT on the diuretic and decongestive effects of oral acetazolamide in Iranian patients with HF. This study will be conducted on heart failure patients whose symptoms of congestion are not relieved by oral diuretics and are temporarily hospitalized in a section called the infusion ward and receive intravenous diuretics. The infusion unit is a separate unit where patients with heart failure who are not adequately relieved by oral diuretics are admitted for a short period of time and receive injectable furosemide. In this study, 250 mg acetazolamide tablets and placebo and furosemide 20 mg will be used. The medical information of the patients will be recorded, patients' clinical status will be evaluated by calculating the EVEREST score at baseline and third day , the weight and laboratory indices will also be measured at baseline and third day based on the same scale and fixed laboratory kits, respectively. Blood pressure will be also measured by an expert nurse at the baseline and each day before the furosemide injection by the same blood pressure cuff. Patients will be followed for clinical events to day 90. The protocol was drafted according to the standard protocol items for clinical trials) SPIRIT) guideline for randomized clinical trial protocols.
Study objectives The main objective is to determine the effect of oral acetazolamide and furosemide, as a loop diuretic, combination therapy on improvement of the congestion in patients at baseline and third day. Urinary sodium to creatinine ratio is an indicator in this objective and will be measured at 2 P.M. in these days.
Prespecified secondary objectives included the following: N-terminal pro B-type natriuretic peptide (NT-proBNP) level on the 30th day, the hospitalization rate in a three-month period, comparison of quality of life between two groups at the end of the third month and change in weight, creatinine level, urinary sodium excretion, potassium level, and hematological indices in complete blood count (CBC) at third day of the trial. At the end of the third month, we will assess our patients' quality of life using the Iranian Heart Failure Quality of Life (IHFQoL) Questionnaire. The validity and reliability of this questionnaire, which has 16 questions in 5 dimentions, has been confirmed by Naderi et al in 2012. (Kornbach's alpha coefficient= 0.922) .This questionnaire offers a range of total scores between 20 and 66. The items are scored on a three- or four-point Likert scale, with a higher score indicating a better quality of life for the individual. These are the five dimensions that are the subject of this survey: severity of disease symptoms (items 1, 2, 3, 4, 6), physical limitations (items 7-1 to 7-6), mental limitations (items 5, 9, 11), social aspects (items 8, 10, 12, 13), self-care (items 14, 15) and the patient's overall satisfaction (item 16). (16)
- Conditions
- Heart Failure
- Being tested
- Acetazolamide, placebo
- Keywords
- : Acetazolamide, Heart failure, Electrolyte Disturbance, Diuretics, Chloride, Diuretic resistance, Decongestion
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideOther
Acetazolamide placebo add-on a standard therapy of iv furosemide in one day and oral furosemide during three consecutive days will be used for the comparator arm
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| acetazolamid | Active comparator | We will administer injectable and oral furosemide in infusion ward based on the dosage determined by the specialist on day zero. After that, we continue oral furosemide administration for three days. The prescribed dose of injectable and oral furosemide is determined by the specialist based on previous visits and hospitalizations in such a way that the patient has the least symptoms. The intervention group will receive acetazolamide 500 mg on day zero, then 250 mg bd for two days and 250 mg on the third day. The control group will receive placebo equivalent to acetazolamide. Receives: Other: Acetazolamide |
| placebo | Placebo comparator | Acetazolamide placebo add-on a standard therapy of iv furosemide in one day and oral furosemide during three consecutive days will be used for the comparator arm. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Na/cr Ratio
. Urinary sodium to creatinine ratio is an indicator in this objective and will be measured at 2 P.M. in these days.
Measured: baseline and third day
Secondary outcomes (2)
N-terminal pro B-type natriuretic peptide (NT-proBNP) level
N-terminal pro B-type natriuretic peptide (NT-proBNP) level
Measured: 30th day
Iranian Heart Failure Quality of Life (IHFQoL) Questionnaire
This questionnaire offers a range of total scores between 20 and 66
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start30 Dec 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940220
- Sponsor's protocol ID
- IR.TUMS.THC.REC.1402.016
- Status last verified
- Jun 2023
- First submitted
- 3 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Acetazolamide as Add-on Diuretic Therapy in Decongestion in Patients With Heart Failure and Diuretic Resistance
- ClinicalTrials.gov ID
- NCT05940220
- Acronym / sponsor ID
- IR.TUMS.THC.REC.1402.016
- Conditions
- Heart Failure
- Keywords
- : Acetazolamide, Heart failure, Electrolyte Disturbance, Diuretics, Chloride, Diuretic resistance, Decongestion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 11 Jul 2023 (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.
This is a 1:1 ratio single-center, double-blind, randomized controlled trial, aiming to enroll 130 patients admitted in infusion ward. The participants receive furosemide as standard treatment and will randomize towards 250 mg oral acetazolamide twice a day versus placebo on three consecutive days. The main objective is to determine the effect of oral acetazolamide and furosemide combination therapy on the decongestion. Prespecified secondary objectives included N-terminal pro B-type natriuretic peptide level on the 30th day, the readmission rate in a three-month period, quality of life assessment by Heart Failure Quality of Life Questionnaire at the end of the third month, change in weight, creatinine level, urinary sodium excretion, potassium level, and hematological indices in complete blood count at third day of the trial.
Detailed description
This is a 1:1 ratio single center, double-blind, RCT on the diuretic and decongestive effects of oral acetazolamide in Iranian patients with HF. This study will be conducted on heart failure patients whose symptoms of congestion are not relieved by oral diuretics and are temporarily hospitalized in a section called the infusion ward and receive intravenous diuretics. The infusion unit is a separate unit where patients with heart failure who are not adequately relieved by oral diuretics are admitted for a short period of time and receive injectable furosemide. In this study, 250 mg acetazolamide tablets and placebo and furosemide 20 mg will be used. The medical information of the patients will be recorded, patients' clinical status will be evaluated by calculating the EVEREST score at baseline and third day , the weight and laboratory indices will also be measured at baseline and third day based on the same scale and fixed laboratory kits, respectively. Blood pressure will be also measured by an expert nurse at the baseline and each day before the furosemide injection by the same blood pressure cuff. Patients will be followed for clinical events to day 90. The protocol was drafted according to the standard protocol items for clinical trials) SPIRIT) guideline for randomized clinical trial protocols.
Study objectives The main objective is to determine the effect of oral acetazolamide and furosemide, as a loop diuretic, combination therapy on improvement of the congestion in patients at baseline and third day. Urinary sodium to creatinine ratio is an indicator in this objective and will be measured at 2 P.M. in these days.
Prespecified secondary objectives included the following: N-terminal pro B-type natriuretic peptide (NT-proBNP) level on the 30th day, the hospitalization rate in a three-month period, comparison of quality of life between two groups at the end of the third month and change in weight, creatinine level, urinary sodium excretion, potassium level, and hematological indices in complete blood count (CBC) at third day of the trial. At the end of the third month, we will assess our patients' quality of life using the Iranian Heart Failure Quality of Life (IHFQoL) Questionnaire. The validity and reliability of this questionnaire, which has 16 questions in 5 dimentions, has been confirmed by Naderi et al in 2012. (Kornbach's alpha coefficient= 0.922) .This questionnaire offers a range of total scores between 20 and 66. The items are scored on a three- or four-point Likert scale, with a higher score indicating a better quality of life for the individual. These are the five dimensions that are the subject of this survey: severity of disease symptoms (items 1, 2, 3, 4, 6), physical limitations (items 7-1 to 7-6), mental limitations (items 5, 9, 11), social aspects (items 8, 10, 12, 13), self-care (items 14, 15) and the patient's overall satisfaction (item 16). (16)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetazolamid | Active comparator | Other: AcetazolamideWe will administer injectable and oral furosemide in infusion ward based on the dosage determined by the specialist on day zero. After that, we continue oral furosemide administration for three days. The prescribed dose of injectable and oral furosemide is determined by the specialist based on previous visits and hospitalizations in such a way that the patient has the least symptoms. The intervention group will receive acetazolamide 500 mg on day zero, then 250 mg bd for two days and 250 mg on the third day. The control group will receive placebo equivalent to acetazolamide. |
| placebo | Placebo comparator | Other: placeboAcetazolamide placebo add-on a standard therapy of iv furosemide in one day and oral furosemide during three consecutive days will be used for the comparator arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Earn at least 8 points from EVEREST score (see Table 1.)
- Adult patients (≥ 18 years)
- A major clinical sign of volume overload including edema, ascites confirmed by abdominal ultrasound, or pleural effusion confirmed by chest x-ray or chest ultrasound without using iv furosemide.
- Maintenance treatment with oral furosemide as a loop diuretic ≥20 mg for at least one month
- Using SGLT2i drugs including canagliflozin, dapagliflozin, and empagliflozin for at least one month
Key exclusion criteria (4 listed)
- Systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg
- Estimated glomerular filtration rate (eGFR) <20 ml/min/1.73 m2
- Using any diuretic agent except mineralocorticoid receptor antagonists including spironolactone and eplerenone
- Simultaneous diagnosis of acute coronary syndrome, which is characterized by typical chest pain in addition to an increase in troponin level above the 99th percentile or electrocardiographic changes indicating ischemia or hospitalization as unstable angina.
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 |
|---|---|---|
| AcetazolamideAcetazolamide placebo add-on a standard therapy of iv furosemide in one day and oral furosemide during three consecutive days will be used for the comparator arm | Other | acetazolamid |
| placeboplacebo | Other | placebo |
Primary outcome
Na/cr Ratio
Time frame: baseline and third day
. Urinary sodium to creatinine ratio is an indicator in this objective and will be measured at 2 P.M. in these days.
2 secondary outcomes
N-terminal pro B-type natriuretic peptide (NT-proBNP) level
Time frame: 30th day
Iranian Heart Failure Quality of Life (IHFQoL) Questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Houshang bavandpour karvane, resident of cardiology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetazolamide in people with Heart Failure, run by Tehran University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 4 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 ALI Bozorgi, Associate Professor ((+9821) 88029758, alibozorgi2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Na/cr Ratio (time frame: baseline and third day). 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 1 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.