Набор скоро начнётся NCT07737964

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

Фаза III С лечением Heart Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Acetazolamide and furosemide, Furosemide.
Кому может быть актуально: Состояния в реестре: Heart Failure. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Препарат Acetazolamide and furosemide
Oral acetazolamide initiated at 500 mg (2 tablets) on Day 0 in addition to standard treatment with loop diuretics. The dose may be adjusted every 48 hours according to the participant's clinical status until Day 5, if necessary.
Препарат Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.

Первичные конечные точки

Percentage of participants with weight loss >2 kg at Day [Срок оценки: Day 5]

Вторичные конечные точки (12)

Efficacy : Percentage of weight variation [Срок оценки: Day 0 to Day 5]
Efficacy : Diuretic effectiveness [Срок оценки: Day 5]
Efficacy : Change in NT-proBNP concentration [Срок оценки: Day 0 to Day 5]
Efficacy : Change in health-related quality of life (EQ-5D-5L) [Срок оценки: Day 0 to Day 5]
Efficacy : Change in dyspnea Visual Analogue Scale (VAS) score [Срок оценки: Day 0 to Day 5]
Efficacy : Rate of unplanned consultation or hospitalization for heart failure [Срок оценки: Day 90]
Efficacy : All-cause mortality [Срок оценки: Day 90]
Efficacy : All-cause mortality and Heart failure-related mortality [Срок оценки: Day 90]
Efficacy : Change in clinical congestion parameters [Срок оценки: At Day 15]
Efficacy : Change in NT-proBNP concentration [Срок оценки: At Day 15]
Safety : Change in serum sodium concentration [Срок оценки: Day 0 to Day 5]
Safety : Percentage of participants with serum sodium <125 mmol/L [Срок оценки: Day 5]

Критерии участия

Критерии включения

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

Критерии исключения

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).