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

13 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

366

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.
Médicament: 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.
Comparateur actif: 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.
Médicament: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of participants with weight loss >2 kg at Day
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Efficacy : Percentage of weight variation
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: Day 90
Percentage of participants requiring an unplanned medical consultation, emergency department visit, or hospitalization for heart failure
Day 90
Efficacy : All-cause mortality
Délai: Day 90
Percentage of participants who die from any cause.
Day 90
Efficacy : All-cause mortality and Heart failure-related mortality
Délai: Day 90
Percentage of participants who die any cause or from heart failure during follow-up.
Day 90
Efficacy : Change in clinical congestion parameters
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Day 5
Percentage of participants presenting serum bicarbonate concentrations below 20 mmol/L on Day 5.
Day 5
Safety: Change in systolic blood pressure
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Montpellier

Les enquêteurs

  • Directeur d'études: François ROUBILLE, MD, University Hospital, Montpellier

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 janvier 2029

Achèvement de l'étude (Estimé)

1 janvier 2029

Dates d'inscription aux études

Première soumission

27 juillet 2026

Première soumission répondant aux critères de contrôle qualité

27 juillet 2026

Première publication (Réel)

30 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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