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Heart FailurePhase 3ACHIEVENCT07737964

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

A Phase 3 study testing Acetazolamide and Furosemide in people with Heart Failure, run by University Hospital, Montpellier at 25 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Acetazolamide and Furosemide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
25 sitesFrance
Study dates
Oct 2026to Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

François ROUBILLE, MD contact

04 67 33 31 82

f-roubille@chu-montpellier.fr

Clément Delmas, MD contact

delmas.clement@chu-toulouse.fr

25 sites in 1 country

France25 sites

  • University Hospital Amiens-Picardie

    Amiens

    Emmanuelle VERMES, MD, 0322087311 ext. 33, vermes.emmanuelle@chu-amiens.fr

    Emmanuelle VERMES, MD

  • University Hospital Angers

    Angers

    Sylvain Grall, MD, 0241353391 ext. 33, sygrall@chu-angers.fr

    Sylvain Grall, MD

  • Avignon Hospital

    Avignon

    Stephane Andrieu, MD, 0432759283 ext. 33, protosavignon@yahoo.fr

    Stephane Andrieu, MD

  • University Hospital Besançon

    Besançon

    Marie France Seronde, MD, 0381668187 ext. 33, mfseronde@chu-besancon.fr

    Marie France Seronde, MD

  • Hospital Beziers

    Béziers

    Frédéric GEORGER, MD, 0467357134 ext. 33, frederic.georger@ch-beziers.fr

    Frederic Georger, MD

  • University Hospital Bordeaux

    Bordeaux

    Sylvain Ploux, MD, 0524549197 ext. 33, sylvain.ploux@chu-bordeaux.fr

    Sylvain Ploux, MD

  • University Hospital Brest

    Brest

    Ombeline Paglia, MD, 0298347505 ext. 33, ombeline.paglia@chu-brest.fr

    Ombeline Paglia, MD

  • University Hospital Caen

    Caen

    Laurence Herrou, MD, 0231064307 ext. 33, herrou-l@chu-caen.fr

    Laurent Herrou, MD

  • Chartres Hospital

    Chartres

    Franck Albert, MD, 0237303057 ext. 33, falbert@ch-chartres.fr

    Franck Albert, MD

  • Cholet Hospital

    Cholet

    Thi-thanh-hien Pham, MD, 0241496985 ext. 33, thi-thanh-hien.pham@ch-cholet.fr

    Thi-thanh-hien Pham, MD

  • Sud Francilien Hospital

    Corbeil-Essonnes

    Fatiha Ait Yahia, MD, 0161693019 ext. 33, fatiha.bouaraba@chsf.fr

    Fatiha Ait Yahia, MD

  • Dreux Hospital

    Dreux

    Dario BOTTIGLIERO, MD, 0237515008 ext. 33, dbottigliero@ch-dreux.fr

    Dario BOTTIGLIERO, MD

  • Cardiovascular Institute - Grenoble Mutualist Hospital Group

    Grenoble

    Benjamin Casez, MD, 0476707516 ext. 33, benjamin.casez@ghm-grenoble.fr

    Benjamin CASEZ, MD

  • University Hospital Grenoble Alpes

    Grenoble

    Muriel Salvat, MD, 0476768888 ext. 33, MSalvat@chu-grenoble.fr

    Muriel Salvat, MD

  • Bicêtre Hospital

    Le Kremlin-Bicêtre

    Emanuelle Berthelot, MD, 0145213735 ext. 33, emmanuelle.berthelot@aphp.fr

    Emmanuelle Berthelot, MD

  • Pôle Santé Sud - Le Mans

    Le Mans

    Christophe Bachelet, MD, 0243784590 ext. 33, christophe.bachelet@me.com

    Christophe Bachelet, MD

  • Louis Pradel Hospital

    Lyon

    Nathan Mewton, MD, 0472357170 ext. 33, nathan.mewton@chu-lyon.fr

    Nathan Mewton, MD

  • University hospital Montpellier

    Montpellier

    François ROUBILLE, MD, 04 67 33 31 82 ext. 33, f-roubille@chu-montpellier.fr

    François Roubille, MD

  • Regional University Hospital Nancy

    Nancy

    Nicolas Girerd, MD, 0383157496 ext. 33, n.girerd@chru-nancy.fr

    Nicolas Girerd, MD

  • The Confluent Private Hospital

    Nantes

    Nicolas Jacob, MD, 0228255115 ext. 33, njacob@vivalto-sante.com

    Nicolas Jacob, MD

  • University Hospital Nîmes

    Nîmes

    Elvira Prunet, MD, 0466683116 ext. 33, elvira.prunet@chu-nimes.fr

    Elvira Prunet, MD

  • Ellipse Center Strasbourg

    Strasbourg

    Florian Zores, MD, 0388859950 ext. 33, florian.zores@gmail.com

    Florian Zores, MD

  • Sainte Musse Hospital Toulon

    Toulon

    Jean-Michel Tartiere, MD, 0494145931 ext. 33, jean-michel.tartiere@ch-toulon.fr

    Jean-Michel TARTIERE, MD

  • University Hospital Toulouse

    Toulouse

    Romain ITIER, MD, 0561322103 ext. 33, itier.r@chu-toulouse.fr

    Clément Delmas, MD, delmas.clement@chu-toulouse.fr

  • Valenciennes Hospital

    Valenciennes

    Thomas Mercier, MD, 0327143041 ext. 33, mercier-t@ch-valenciennes.fr

    Thomas Mercier, MD

Other trials in France

About this study

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.

Conditions
Heart Failure
Being tested
Acetazolamide, Furosemide
Keywords
heart failure, congestion, ambulatory treatment, remote telemonitoring, diuretics
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcetazolamideDrug

    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.

  • FurosemideDrug

    Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.

Study groups in NCT07737964
Study groupRoleWhat they receive
Experimental group - AcetazolamideExperimentalAmbulatory 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.
Receives: Drug: Acetazolamide; Drug: Furosemide
Control group - Standard treatmentActive 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.
Receives: Drug: Furosemide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 5

Secondary outcomes (22)

  1. Efficacy : Percentage of weight variation

    Percentage change in body weight between Day 0 and Day 5 measured using a connected scale through the remote telemonitoring system.

    Measured: Day 0 to Day 5

  2. Efficacy : Diuretic effectiveness

    Diuretic effectiveness assessed by urinary sodium excretion (natriuresis) corrected for loop diuretic exposure, expressed according to furosemide-equivalent dose administered up to Day 5.

    Measured: Day 5

  3. Efficacy : Change in NT-proBNP concentration

    Change in plasma NT-proBNP concentration measured from blood samples between baseline and Day 5.

    Measured: Day 0 to Day 5

  4. Efficacy : Change in health-related quality of life (EQ-5D-5L)

    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).

    Measured: Day 0 to Day 5

  5. Efficacy : Change in dyspnea Visual Analogue Scale (VAS) score

    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).

    Measured: Day 0 to Day 5

  6. Efficacy : Rate of unplanned consultation or hospitalization for heart failure

    Percentage of participants requiring an unplanned medical consultation, emergency department visit, or hospitalization for heart failure

    Measured: Day 90

  7. Efficacy : All-cause mortality

    Percentage of participants who die from any cause.

    Measured: Day 90

  8. Efficacy : All-cause mortality and Heart failure-related mortality

    Percentage of participants who die any cause or from heart failure during follow-up.

    Measured: Day 90

  9. Efficacy : Change in clinical congestion parameters

    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.

    Measured: At Day 15

  10. Efficacy : Change in NT-proBNP concentration

    Change in plasma NT-proBNP concentration measured on blood samples collected after the acute treatment period.

    Measured: At Day 15

  11. Safety : Change in serum sodium concentration

    Assessment of the change in serum sodium concentration between baseline Day 0 and Day 5 to evaluate electrolyte disturbances associated with treatment.

    Measured: Day 0 to Day 5

  12. Safety : Percentage of participants with serum sodium <125 mmol/L

    Percentage of participants presenting severe hyponatremia, defined as a serum sodium concentration below 125 mmol/L, on Day 5.

    Measured: Day 5

  13. Safety: Incidence of acute kidney injury (KDIGO stage ≥2)

    Percentage of participants developing acute kidney injury defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or higher between D0 and D5.

    Measured: Day 0 to Day 5

  14. Safety : Change in serum potassium concentration

    Assessment of the change in serum potassium concentration between baseline Day 0 and Day 5 to evaluate treatment related electrolyte abnormalities.

    Measured: Day 0 to Day 5

  15. Safety: Percentage of participants with serum potassium <2.5 mmol/L

    Percentage of participants presenting severe hypokalemia, defined as a serum potassium concentration below 2.5 mmol/L, on Day 5.

    Measured: Day 5

  16. Safety: Change in serum bicarbonate concentration from 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.

    Measured: Day 0 to Day 5

  17. Percentage of participants with serum bicarbonate <20 mmol/L

    Percentage of participants presenting serum bicarbonate concentrations below 20 mmol/L on Day 5.

    Measured: Day 5

  18. Safety: Change in systolic blood pressure

    Assessment of the change in systolic blood pressure between baseline Day 0 and Day 5 during treatment.

    Measured: Day 0 to Day 5

  19. Safety: Percentage of participants with systolic blood pressure <90 mmHg

    Percentage of participants presenting systolic blood pressure below 90 mmHg during treatment.

    Measured: Day 0 to day 5

  20. Safety: Incidence of low cardiac output or cardiogenic shock

    Percentage of participants developing low cardiac output syndrome or cardiogenic shock between D0 and D5.

    Measured: Day 0 to Day 5

  21. Safety: Hospitalization due to treatment failure or poor treatment tolerance

    Percentage of participants requiring hospitalization because of treatment failure or poor treatment tolerance.

    Measured: Day 5 and Day 15

  22. Medicoeconomic: Hospital medical costs

    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.

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This multicenter, prospective, randomized, controlled, open-label, superiority Phase III trial compares two parallel groups: standard decongestion with loop diuretics (control group) versus standard decongestion plus oral acetazolamide (experimental group) in ambulatory patients with decompensated heart failure monitored by remote telemonitoring.
Masking
None (open label)
Enrolment
366 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07737964
Sponsor's protocol ID
RECHMPL24_0295
Other IDs
2025-524344-35-00, 2025
Acronym
ACHIEVE
Status last verified
Jul 2026
First submitted
27 Jul 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetazolamide and Furosemide in people with Heart Failure, run by University Hospital, Montpellier at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François ROUBILLE, MD (04 67 33 31 82, f-roubille@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with weight loss >2 kg at Day (time frame: Day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07737964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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