ACetazolamide in Patients With Heart Failure, to Decrease Weight and relIEVE Symptoms.
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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®)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Acetazolamide
DrugOral 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
DrugStandard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.
Treatment groups
366 Participants
are divided into 2 treatment groupsGroup A: Experimental group - AcetazolamideExperimental treatment 2 interventions
Group B: Control group - Standard treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Day 5Secondary outcomes
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.
Time frame
Day 0 to Day 52
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.
Time frame
Day 53
Efficacy : Change in NT-proBNP concentration
Change in plasma NT-proBNP concentration measured from blood samples between baseline and Day 5.
Time frame
Day 0 to Day 54
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).
Time frame
Day 0 to Day 5Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: