Acetazolamide added to usual treatment for fluid buildup in heart failure

Trial details

Who runs it

University Hospital, Montpellier

Trial code

NCT07737964EU 2025-524344-35-00

Record updated

17 August 2026

Original description

Acute congestion is common in patients with heart failure (HF) and is associated with impaired renal function, reduced quality of life, hospital readmissions, and mortality. Current guidelines recommend optimal decongestion using diuretic therapy, mainly loop diuretics. Although acetazolamide has recently demonstrated efficacy in hospitalized patients, its role in ambulatory patients managed through remote telemonitoring remains to be established. This study aims to evaluate the efficacy of oral acetazolamide added to conventional treatment for decongesting ambulatory HF patients during congestive decompensations.Read full original descriptionShow less

ACetazolamide in Patients With Heart Failure, to Decrease Weight and relIEVE Symptoms.

Acute congestion is common in patients with heart failure (HF) and is associated with impaired renal function, reduced quality of life, hospital readmissions, and mortality. Current guidelines recommend optimal decongestion using diuretic therapy, mainly loop diuretics. Although acetazolamide has recently demonstrated efficacy in hospitalized patients, its role in ambulatory patients managed through remote telemonitoring remains to be established. This study aims to evaluate the efficacy of oral acetazolamide added to conventional treatment for decongesting ambulatory HF patients during congestive decompensations.

ACHIEVE is a Phase III multicenter, prospective, interventional, randomized, controlled, open-label superiority trial evaluating the efficacy of oral acetazolamide added to conventional treatment for decongestion in ambulatory patients with heart failure during congestive decompensation monitored by remote telemonitoring.

The primary objective is to assess, at Day 5, whether acetazolamide added to conventional treatment improves decongestion compared with standard treatment alone. Secondary objectives include evaluating efficacy, safety, and health economic outcomes, including quality of life, dyspnea, biological markers, unplanned consultations, hospitalizations, mortality, and hospital medical costs.

Inclusion: Age ≥ 18; Known HF with impaired, midly-reduced or preserved LVEF; Under guideline directed medical therapy for HF according to ESC Heart Failure Guidelines applicable at inclusion; Previously followed (or included at hospital discharge) by remote monitoring allowing daily weight by connected scale (i.e. Careline®, Optified-self®, NewCard®, Implicity®); Under furosemide diuretic treatment ≥ 20mg/day for at least 30 days prior to inclusion; Current unplanned hospitalization or unplanned/emergent consultation for acute/decompensation HF.

Exclusion: Concurrent participation in another interventional study; Concomitant use of carbamazepine or quinidinics (hydroquinidine, quinidine); Current use of acetazolamide or any other carbonic anhydrase inhibitor, including but not limited to topical ophthalmic formulations (e.g., brinzolamide, dorzolamide, methazolamide); Concomitant use of lithium, valproic acid and valpromide; Chronic ventricular assist device or heart transplant patients; Acute heart failure from recent acute coronary syndrome (< 1 month); History of renal colic, hyperchloremic acidosis and wheat allergy (other than coeliac disease); Low cardiac output syndrome/cardiogenic shock; Severe chronic renal failure or dialysis (GFR < 20 ml/min); Known severe hepatic insufficiency defined by a PTT < 50% or a Child-Pugh score C and/or a known (clinial or biological) supplemented adrenal insufficiency; Hypersensitivity to the active substance (Acetazolamide) or to any of the excipients (Calcium carbonate, wheat starch, gelatine, magnesium stearate); Subject unable to express their consent and sign informed consent form; Subject not covered by public health insurance; Refusal to participate (absence of informed consent); Subject under guardianship, legal protection, or deprived of liberty; Pregnant or breastfeeding women; Subject under law protection and prisoners; Women of child bearing potential, unless they are using an effective method of birth control (i.e. oral contraceptives, implantable contraceptives, injectable contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner); Subject unable to comprehend or adhere to the protocol and follow-up; Intolerance to sulphonamides; Current use of high-dose aspirin (>300 mg/day); Non-randomization criteria (Criteria should be controlled before patients' randomization) :; False alarm; Time between alarm and randomization > 48h; Subject who declines his participation; Loss of study treatments or unable to take it at D0; Hemodynamic instability justifying an urgent hospitalization; If applicable, positive urine pregnancy test.

ClinicalTrials.gov NCT07737964 · EU CTIS 2025-524344-35-00