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

Starting soon · Phase 3

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT07737964

Run by

University Hospital, Montpellier

People needed

366

Starts

2026-10-01

Expected to finish

2029-01-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Concurrent participation in another interventional study.
• Chronic ventricular assist device or heart transplant patients.
• Acute heart failure from recent acute coronary syndrome (< 1 month).
• Severe chronic renal failure or dialysis (GFR < 20 ml/min).
• History of renal colic, hyperchloremic acidosis and wheat allergy (other than coeliac disease)
• 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
• Intolerance to sulphonamides
• Hypersensitivity to the active substance (Acetazolamide) or to any of the excipients (Calcium carbonate, wheat starch, gelatine, magnesium stearate)
• Concomitant use of carbamazepine or quinidinics (hydroquinidine, quinidine)
• Low cardiac output syndrome/cardiogenic shock.
• 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
• 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

Where it is running

• University Hospital Amiens-Picardie — Amiens, France
• University Hospital Angers — Angers, France
• Avignon Hospital — Avignon, France
• University Hospital Besançon — Besançon, France
• Hospital Beziers — Béziers, France
• University Hospital Bordeaux — Bordeaux, France
• University Hospital Brest — Brest, France
• University Hospital Caen — Caen, France
• Chartres Hospital — Chartres, France
• Cholet Hospital — Cholet, France
• Sud Francilien Hospital — Corbeil-Essonnes, France
• Dreux Hospital — Dreux, France
• Cardiovascular Institute - Grenoble Mutualist Hospital Group — Grenoble, France
• University Hospital Grenoble Alpes — Grenoble, France
• Bicêtre Hospital — Le Kremlin-Bicêtre, France
• Pôle Santé Sud - Le Mans — Le Mans, France
• Louis Pradel Hospital — Lyon, France
• University hospital Montpellier — Montpellier, France
• Regional University Hospital Nancy — Nancy, France
• The Confluent Private Hospital — Nantes, France
• University Hospital Nîmes — Nîmes, France
• Ellipse Center Strasbourg — Strasbourg, France
• Sainte Musse Hospital Toulon — Toulon, France
• University Hospital Toulouse — Toulouse, France
• Valenciennes Hospital — Valenciennes, France

Full record on ClinicalTrials.gov

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