Acute Decompensated Heart FailureNCT07199088
Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure
A study testing Acetazolamide and Metolazone in people with Acute Decompensated Heart Failure and Heart Failure, Diastolic, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
This clinical trial aims to compare the efficacy and safety of acetazolamide versus metolazone as adjunctive treatments to standard therapy in patients with acute decompensated heart failure (ADHF). ADHF is a life-threatening condition, and current treatments often involve loop diuretics to alleviate volume overload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic
- What is being tested?
- Acetazolamide and Metolazone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Oct 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 years or older.
- Diagnosed with Acute Decompensated Heart Failure (ADHF), with either preserved or reduced ejection fraction (EF).
- At least one clinical sign of volume overload, such as:
- Pleural effusion (confirmed by chest X-ray or ultrasound).
- Oedema or ascites (verified by abdominal ultrasonography).
- Plasma NT-proBNP level > 1000 pg/mL or BNP level > 250 ng/mL at screening.
- Receiving at least 40 mg of furosemide as oral maintenance therapy for at least one month prior to the study initiation.
Who cannot join
- Previous use of acetazolamide or metolazone prior to the study period.
- Known hypersensitivity or allergies to the study drugs (acetazolamide or metolazone) or their components.
- Patients with electrolyte disturbances, especially hypokalemia.
- End-stage renal disease requiring dialysis or GFR < 20 mL/min/1.73 m².
- Pregnant or breastfeeding women.
- Severe hypotension (systolic blood pressure < 90 mmHg) or other significant comorbidities like congenital cardiac illness requiring surgery.
- Patients requiring renal replacement therapy during the hospitalization.
- History of significant electrolyte imbalances or acid-base disturbances.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Quaid e Azam Medical College , bahawalpur
Chak Eighty-seven -Twelve Left, Punjab Province
Matiullah Azmoon Dr, 03221639240, matiullahazmoon@gmail.com
About this study
This clinical trial aims to compare the efficacy and safety of acetazolamide versus metolazone as adjunctive treatments to standard therapy in patients with acute decompensated heart failure (ADHF). ADHF is a life-threatening condition, and current treatments often involve loop diuretics to alleviate volume overload. This study will assess the added benefit of acetazolamide and metolazone in improving decongestion, reducing hospital stays, and preventing complications such as renal dysfunction or electrolyte imbalances. Participants will be randomized to receive either acetazolamide or metolazone in addition to standard diuretic therapy. The trial will evaluate primary outcomes including successful decongestion, in-hospital mortality, and length of hospital stay, with secondary outcomes focusing on renal function, electrolyte disturbances, and overall safety. The study is conducted at Bahawal Victoria Hospital, Bahawalpur, and aims to provide valuable insights into the management of ADHF, especially in the Pakistani population.
- Being tested
- Acetazolamide, Metolazone
- Medical subject headings
- Heart Failure, Diastolic, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideOther
A carbonic anhydrase inhibitor, 500 mg orally once a day as an adjunct to loop diuretics for enhancing diuresis and improving decongestion in ADHF patients.
MetolazoneOther
A thiazide-like diuretic, 5 mg orally once a day as an adjunct to loop diuretics for enhancing diuresis and improving decongestion in ADHF patients.
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide + Standard Therapy | Experimental | Participants in this group will receive acetazolamide (500 mg/day) as an adjunct to standard heart failure therapy, which includes intravenous loop diuretics (Furosemide 80 mg/day). This group aims to assess the efficacy and safety of acetazolamide in improving decongestion in patients with acute decompensated heart failure. Receives: Other: Acetazolamide |
| Metolazone Group | Active comparator | Participants in this group will receive metolazone (5 mg/day) as an adjunct to standard heart failure therapy, including intravenous loop diuretics (Furosemide 80 mg/day). This group serves as a comparison to the acetazolamide group, evaluating the efficacy and safety of metolazone in improving decongestion in patients with acute decompensated heart failure. Receives: Other: Metolazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Decongestion
This outcome measure assesses the resolution of clinical signs and symptoms of acute decompensated heart failure (ADHF), specifically the absence of orthopnea, reduced jugular venous distention (JVD) to <8 cm H2O, and minimal or no peripheral edema. Successful decongestion is considered when these signs are resolved within 72 hours of intervention.
Measured: 72 hours after randomization (following 3 days of treatment with the assigned adjunct therapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start11 Oct 2025 (estimated)
- Primary completion16 Oct 2026 (estimated)
- Study completion30 Oct 2026 (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.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Matiullah Azmoon, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199088
- Sponsor's protocol ID
- 772
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- 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 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07199088
- Acronym / sponsor ID
- 772
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 11 Oct 2025 (estimated)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 30 Sep 2025 (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 clinical trial aims to compare the efficacy and safety of acetazolamide versus metolazone as adjunctive treatments to standard therapy in patients with acute decompensated heart failure (ADHF). ADHF is a life-threatening condition, and current treatments often involve loop diuretics to alleviate volume overload. This study will assess the added benefit of acetazolamide and metolazone in improving decongestion, reducing hospital stays, and preventing complications such as renal dysfunction or electrolyte imbalances. Participants will be randomized to receive either acetazolamide or metolazone in addition to standard diuretic therapy. The trial will evaluate primary outcomes including successful decongestion, in-hospital mortality, and length of hospital stay, with secondary outcomes focusing on renal function, electrolyte disturbances, and overall safety. The study is conducted at Bahawal Victoria Hospital, Bahawalpur, and aims to provide valuable insights into the management of ADHF, especially in the Pakistani population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide + Standard Therapy | Experimental | Other: AcetazolamideParticipants in this group will receive acetazolamide (500 mg/day) as an adjunct to standard heart failure therapy, which includes intravenous loop diuretics (Furosemide 80 mg/day). This group aims to assess the efficacy and safety of acetazolamide in improving decongestion in patients with acute decompensated heart failure. |
| Metolazone Group | Active comparator | Other: MetolazoneParticipants in this group will receive metolazone (5 mg/day) as an adjunct to standard heart failure therapy, including intravenous loop diuretics (Furosemide 80 mg/day). This group serves as a comparison to the acetazolamide group, evaluating the efficacy and safety of metolazone in improving decongestion in patients with acute decompensated heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older.
- Diagnosed with Acute Decompensated Heart Failure (ADHF), with either preserved or reduced ejection fraction (EF).
- At least one clinical sign of volume overload, such as:
- Pleural effusion (confirmed by chest X-ray or ultrasound).
- Oedema or ascites (verified by abdominal ultrasonography).
Key exclusion criteria (8 listed)
- Previous use of acetazolamide or metolazone prior to the study period.
- Known hypersensitivity or allergies to the study drugs (acetazolamide or metolazone) or their components.
- Patients with electrolyte disturbances, especially hypokalemia.
- End-stage renal disease requiring dialysis or GFR < 20 mL/min/1.73 m².
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| AcetazolamideA carbonic anhydrase inhibitor, 500 mg orally once a day as an adjunct to loop diuretics for enhancing diuresis and improving decongestion in ADHF patients. | Other | Acetazolamide + Standard Therapy |
| MetolazoneA thiazide-like diuretic, 5 mg orally once a day as an adjunct to loop diuretics for enhancing diuresis and improving decongestion in ADHF patients. | Other | Metolazone Group |
Primary outcome
Successful Decongestion
Time frame: 72 hours after randomization (following 3 days of treatment with the assigned adjunct therapy).
This outcome measure assesses the resolution of clinical signs and symptoms of acute decompensated heart failure (ADHF), specifically the absence of orthopnea, reduced jugular venous distention (JVD) to <8 cm H2O, and minimal or no peripheral edema. Successful decongestion is considered when these signs are resolved within 72 hours of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetazolamide and Metolazone in people with Acute Decompensated Heart Failure and Heart Failure, Diastolic, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matiullah Azmoon (03221639240, matiullahazmoon@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: 72 hours after randomization (following 3 days of treatment with the assigned adjunct therapy).). 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 3 Oct 2025.