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

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Jul 30, 2026

Start date

Oct 31, 2026

Status verified

Jul 2026

Primary completion

Jan 31, 2029

Completion

Jan 31, 2029

Study Design

Enrollment

366 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• Active Comparator: 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.

Primary Outcome Measure

Percentage of participants with weight loss >2 kg at Day [ Time Frame: Day 5 ]

Central Contacts

• François ROUBILLE, MD
  04 67 33 31 82
  [email protected]
• Clément Delmas, MD
  [email protected]

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