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NCT Number: NCT07737964

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Amiens-Picardie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetazolamide

Drug

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.

Furosemide

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  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).

  6. 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

  7. Efficacy : All-cause mortality

    Time frame: Day 90

    Percentage of participants who die from any cause.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clément Delmas, MD

CONTACT

[email protected]

François ROUBILLE, MD

CONTACT

[email protected]

04 67 33 31 82

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: ACHIEVE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 30, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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