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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours after randomization (following 3 days of treatment with the assigned adjunct therapy). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matiullah Azmoon | Contact | 03221639240 | matiullahazmoon@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quaid e Azam Medical College , bahawalpur | Recruiting | Chak Four Hundred Fifty-four | Punjab Province | Pakistan |
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| Metolazone | Other | 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. |
|
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| D008788 | Metolazone |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D052999 | Quinazolinones |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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