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

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

Qualifiers

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®)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Acetazolamide
  • Furosemide

Treatment groups

366 Participants
are divided into 2 treatment groups