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

13 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

366

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.
Geneesmiddel: 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.
Actieve vergelijker: 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.
Geneesmiddel: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of participants with weight loss >2 kg at Day
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Montpellier

Onderzoekers

  • Studie directeur: François ROUBILLE, MD, University Hospital, Montpellier

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 januari 2029

Studie voltooiing (Geschat)

1 januari 2029

Studieregistratiedata

Eerst ingediend

27 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 juli 2026

Eerst geplaatst (Werkelijk)

30 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

13 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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