Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure

Not Applicable

Recruiting

• Conditions: Acute Decompensated Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic

• Registration Number: NCT07199088
• Lead Sponsor: University of Health Sciences Lahore

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-21
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-10-03
• Study Start: 2025-10-11
• Primary Completion: 2026-10-16
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Successful Decongestion	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.

Trial Locations

Locations (1)

Quaid e Azam Medical College , bahawalpur; 🇵🇰 Chak Eighty-seven -Twelve Left, Punjab Province, Pakistan