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NCT Number: NCT07199088

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

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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Key information

Conditions

Acute Decompensated Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Diastolic Heart Failure, Systolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quaid e Azam Medical College , bahawalpur

Chak Four Hundred Fifty-four, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Matiullah Azmoon Dr

CONTACT

[email protected]

03221639240

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matiullah Azmoon

CONTACT

[email protected]

03221639240

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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