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

NCT ID: NCT07199088

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-11
• Study Completion Date: 2026-10-30

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.

Conditions

Acute Decompensated Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acetazolamide + Standard Therapy

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.

Group Type: EXPERIMENTAL

Acetazolamide

Intervention Type: 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.

Metolazone Group

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.

Group Type: ACTIVE_COMPARATOR

Metolazone

Intervention Type: 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.

Interventions

Acetazolamide

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.

Intervention Type: OTHER

Metolazone

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

Dr. Matiullah Azmoon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Quaid e Azam Medical College , bahawalpur

Chak Eighty-seven -Twelve Left, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Matiullah Azmoon

Role: CONTACT

matiullahazmoon@gmail.com

03221639240

Facility Contacts

Matiullah Azmoon Dr

Role: primary

matiullahazmoon@gmail.com

03221639240

Other Identifiers

772

Identifier Type: -

Identifier Source: org_study_id