ACetazolamide in Patients With Heart Failure, to Decrease Weight and relIEVE Symptoms.
ACHIEVE
2 other identifiers
interventional
366
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
Started Oct 2026
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
Study Completion
Last participant's last visit for all outcomes
January 1, 2029
July 30, 2026
July 1, 2026
2.3 years
July 27, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with weight loss >2 kg at Day
Percentage of participants who achieve a body weight loss greater than 2 kg between baseline (Day 0) and Day 5, measured using a connected scale through the remote telemonitoring system. Comparison between the experimental and control groups.
Day 5
Secondary Outcomes (22)
Efficacy : Percentage of weight variation
Day 0 to Day 5
Efficacy : Diuretic effectiveness
Day 5
Efficacy : Change in NT-proBNP concentration
Day 0 to Day 5
Efficacy : Change in health-related quality of life (EQ-5D-5L)
Day 0 to Day 5
Efficacy : Change in dyspnea Visual Analogue Scale (VAS) score
Day 0 to Day 5
- +17 more secondary outcomes
Study Arms (2)
Experimental group - Acetazolamide
EXPERIMENTALAmbulatory patients with decompensated heart failure receiving standard treatment with loop diuretics (furosemide) plus oral acetazolamide for up to 5 days. Treatment effectiveness and safety are assessed daily using remote telemonitoring data.
Control group - Standard treatment
ACTIVE COMPARATORAmbulatory patients with decompensated heart failure receiving standard treatment with loop diuretics (furosemide) alone for up to 5 days. Treatment effectiveness and safety are assessed daily using remote telemonitoring data.
Interventions
Oral acetazolamide initiated at 500 mg (2 tablets) on Day 0 in addition to standard treatment with loop diuretics. The dose may be adjusted every 48 hours according to the participant's clinical status until Day 5, if necessary.
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.
Eligibility Criteria
You may qualify if:
- Age ≥ 18
- Known HF with impaired, midly-reduced or preserved LVEF
- Previously followed (or included at hospital discharge) by remote monitoring allowing daily weight by connected scale (i.e. Careline®, Optified-self®, NewCard®, Implicity®)
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
François ROUBILLE, MD
University Hospital, Montpellier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2026
First Posted
July 30, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
July 30, 2026
Record last verified: 2026-07