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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Health Sciences Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older.

Diagnosed with Acute Decompensated Heart Failure (ADHF), with either preserved or reduced ejection fraction (EF).

Pleural effusion (confirmed by chest X-ray or ultrasound).

Oedema or ascites (verified by abdominal ultrasonography).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetazolamide

    Other intervention

    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 intervention

    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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Acetazolamide + Standard TherapyExperimental treatment 1 intervention
Group B: Metolazone GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
72 hours after randomization (following 3 days of treatment with the assigned adjunct therapy).

Secondary outcomes

Other outcomes

Sponsors and contacts

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