Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

13 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

366

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.
Droga: 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.
Comparador activo: 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.
Droga: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of participants with weight loss >2 kg at Day
Periodo de tiempo: 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

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital, Montpellier

Investigadores

  • Director de estudio: François ROUBILLE, MD, University Hospital, Montpellier

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de enero de 2029

Finalización del estudio (Estimado)

1 de enero de 2029

Fechas de registro del estudio

Enviado por primera vez

27 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de julio de 2026

Publicado por primera vez (Actual)

30 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir