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

August 13, 2026 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

366

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • University Hospital Amiens-Picardie
        • Contact:
        • Principal Investigator:
          • Emmanuelle VERMES, MD
      • Angers, France
        • University Hospital Angers
        • Contact:
        • Principal Investigator:
          • Sylvain Grall, MD
      • Avignon, France
        • Avignon Hospital
        • Principal Investigator:
          • Stephane Andrieu, MD
        • Contact:
      • Besançon, France
        • University Hospital Besançon
        • Principal Investigator:
          • Marie France Seronde, MD
        • Contact:
      • Bordeaux, France
        • University Hospital Bordeaux
        • Contact:
        • Principal Investigator:
          • Sylvain Ploux, MD
      • Brest, France
        • University Hospital Brest
        • Contact:
        • Principal Investigator:
          • Ombeline Paglia, MD
      • Béziers, France
        • Hospital Beziers
        • Contact:
        • Principal Investigator:
          • Frederic Georger, MD
      • Caen, France
        • University Hospital Caen
        • Contact:
        • Principal Investigator:
          • Laurent Herrou, MD
      • Chartres, France
        • Chartres Hospital
        • Contact:
        • Principal Investigator:
          • Franck Albert, MD
      • Cholet, France
        • Cholet Hospital
        • Contact:
        • Principal Investigator:
          • Thi-thanh-hien Pham, MD
      • Corbeil-Essonnes, France
        • Sud Francilien Hospital
        • Contact:
        • Principal Investigator:
          • Fatiha Ait Yahia, MD
      • Dreux, France
        • Dreux Hospital
        • Contact:
        • Principal Investigator:
          • Dario BOTTIGLIERO, MD
      • Grenoble, France
        • University Hospital Grenoble Alpes
        • Contact:
        • Principal Investigator:
          • Muriel Salvat, MD
      • Grenoble, France
        • Cardiovascular Institute - Grenoble Mutualist Hospital Group
        • Contact:
        • Principal Investigator:
          • Benjamin CASEZ, MD
      • Le Kremlin-Bicêtre, France
        • Bicetre Hospital
        • Contact:
        • Principal Investigator:
          • Emmanuelle Berthelot, MD
      • Le Mans, France
        • Pôle Santé Sud - Le Mans
        • Contact:
        • Principal Investigator:
          • Christophe Bachelet, MD
      • Lyon, France
        • Louis Pradel Hospital
        • Contact:
        • Principal Investigator:
          • Nathan Mewton, MD
      • Montpellier, France
        • University hospital Montpellier
        • Principal Investigator:
          • François Roubille, MD
        • Contact:
      • Nancy, France
        • Regional University Hospital Nancy
        • Principal Investigator:
          • Nicolas Girerd, MD
        • Contact:
      • Nantes, France
        • The Confluent Private Hospital
        • Contact:
        • Principal Investigator:
          • Nicolas Jacob, MD
      • Nîmes, France
        • University Hospital Nîmes
        • Contact:
        • Principal Investigator:
          • Elvira Prunet, MD
      • Strasbourg, France
        • Ellipse Center Strasbourg
        • Contact:
        • Principal Investigator:
          • Florian Zores, MD
      • Toulon, France
        • Sainte Musse Hospital Toulon
        • Contact:
        • Principal Investigator:
          • Jean-Michel TARTIERE, MD
      • Toulouse, France
      • Valenciennes, France
        • Valenciennes Hospital
        • Contact:
        • Principal Investigator:
          • Thomas Mercier, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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
  • Loss of study treatments or unable to take it at D0
  • Hemodynamic instability justifying an urgent hospitalization
  • If applicable, positive urine pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group - Acetazolamide
Ambulatory 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.
Drug: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.
Drug: Acetazolamide
Oral acetazolamide initiated at 500 mg (2 tablets) on Day 0. The dose may be adjusted every 48 hours according to the participant's clinical status until Day 5, if necessary.
Active Comparator: Control group - Standard treatment
Ambulatory 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.
Drug: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with weight loss >2 kg at Day
Time Frame: Day 5
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy : Percentage of weight variation
Time Frame: Day 0 to Day 5
Percentage change in body weight between Day 0 and Day 5 measured using a connected scale through the remote telemonitoring system.
Day 0 to Day 5
Efficacy : Diuretic effectiveness
Time Frame: Day 5
Diuretic effectiveness assessed by urinary sodium excretion (natriuresis) corrected for loop diuretic exposure, expressed according to furosemide-equivalent dose administered up to Day 5.
Day 5
Efficacy : Change in NT-proBNP concentration
Time Frame: Day 0 to Day 5
Change in plasma NT-proBNP concentration measured from blood samples between baseline and Day 5.
Day 0 to Day 5
Efficacy : Change in health-related quality of life (EQ-5D-5L)
Time Frame: Day 0 to Day 5
Change in EQ-5D-5L score between baseline (Day 0) and Day 5. The EQ-5D-5L is a validated generic quality-of-life questionnaire assessing five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).Each question has 5 levels of answers: No problem, slight problems, moderate problems, severe problems and unable to/ extreme problems. It also includes a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Day 0 to Day 5
Efficacy : Change in dyspnea Visual Analogue Scale (VAS) score
Time Frame: Day 0 to Day 5
Change in dyspnea severity assessed using a Visual Analogue Scale (VAS) between baseline (Day 0) and Day 5. The VAS ranges from 0 (no shortness of breath) to 10 (worst shortness of breath imaginable).
Day 0 to Day 5
Efficacy : Rate of unplanned consultation or hospitalization for heart failure
Time Frame: Day 90
Percentage of participants requiring an unplanned medical consultation, emergency department visit, or hospitalization for heart failure
Day 90
Efficacy : All-cause mortality
Time Frame: Day 90
Percentage of participants who die from any cause.
Day 90
Efficacy : All-cause mortality and Heart failure-related mortality
Time Frame: Day 90
Percentage of participants who die any cause or from heart failure during follow-up.
Day 90
Efficacy : Change in clinical congestion parameters
Time Frame: At Day 15
Evolution of clinical congestion including body weight, dyspnea VAS score, blood pressure, heart rate, and signs of right- and left-sided heart failure collected during follow-up visits.
At Day 15
Efficacy : Change in NT-proBNP concentration
Time Frame: At Day 15
Change in plasma NT-proBNP concentration measured on blood samples collected after the acute treatment period.
At Day 15
Safety : Change in serum sodium concentration
Time Frame: Day 0 to Day 5
Assessment of the change in serum sodium concentration between baseline Day 0 and Day 5 to evaluate electrolyte disturbances associated with treatment.
Day 0 to Day 5
Safety : Percentage of participants with serum sodium <125 mmol/L
Time Frame: Day 5
Percentage of participants presenting severe hyponatremia, defined as a serum sodium concentration below 125 mmol/L, on Day 5.
Day 5
Safety: Incidence of acute kidney injury (KDIGO stage ≥2)
Time Frame: Day 0 to Day 5
Percentage of participants developing acute kidney injury defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or higher between D0 and D5.
Day 0 to Day 5
Safety : Change in serum potassium concentration
Time Frame: Day 0 to Day 5
Assessment of the change in serum potassium concentration between baseline Day 0 and Day 5 to evaluate treatment related electrolyte abnormalities.
Day 0 to Day 5
Safety: Percentage of participants with serum potassium <2.5 mmol/L
Time Frame: Day 5
Percentage of participants presenting severe hypokalemia, defined as a serum potassium concentration below 2.5 mmol/L, on Day 5.
Day 5
Safety: Change in serum bicarbonate concentration from Day 0 to Day 5
Time Frame: Day 0 to Day 5
Assessment of the change in serum bicarbonate concentration between baseline Day 0 and Day 5 to evaluate metabolic changes associated with treatment.
Day 0 to Day 5
Percentage of participants with serum bicarbonate <20 mmol/L
Time Frame: Day 5
Percentage of participants presenting serum bicarbonate concentrations below 20 mmol/L on Day 5.
Day 5
Safety: Change in systolic blood pressure
Time Frame: Day 0 to Day 5
Assessment of the change in systolic blood pressure between baseline Day 0 and Day 5 during treatment.
Day 0 to Day 5
Safety: Percentage of participants with systolic blood pressure <90 mmHg
Time Frame: Day 0 to day 5
Percentage of participants presenting systolic blood pressure below 90 mmHg during treatment.
Day 0 to day 5
Safety: Incidence of low cardiac output or cardiogenic shock
Time Frame: Day 0 to Day 5
Percentage of participants developing low cardiac output syndrome or cardiogenic shock between D0 and D5.
Day 0 to Day 5
Safety: Hospitalization due to treatment failure or poor treatment tolerance
Time Frame: Day 5 and Day 15
Percentage of participants requiring hospitalization because of treatment failure or poor treatment tolerance.
Day 5 and Day 15
Medicoeconomic: Hospital medical costs
Time Frame: Day 90
Difference in direct hospital medical costs related to unplanned consultations, emergency department visits, or hospitalizations between the experimental and control groups. Costs will be assessed using actual reimbursement tariffs and hospital revenues.
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: François ROUBILLE, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

July 27, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL24_0295
  • 2025-524344-35-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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