ACetazolamide in Patients With Heart Failure, to Decrease Weight and relIEVE Symptoms.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 366
- 试验地点
- 25
- 主要终点
- Percentage of participants with weight loss >2 kg at Day
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Acetazolamide (Drug)
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.
干预措施: Furosemide (Drug)
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.
干预措施: Furosemide (Drug)
结局指标
主要结局
Percentage of participants with weight loss >2 kg at Day
时间窗: 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.
次要结局
- Efficacy : Percentage of weight variation(Day 0 to Day 5)
- Efficacy : Diuretic effectiveness(Day 5)
- Efficacy : Change in NT-proBNP concentration(Day 0 to Day 5)
- Efficacy : Change in health-related quality of life (EQ-5D-5L)(Day 0 to Day 5)
- Efficacy : Change in dyspnea Visual Analogue Scale (VAS) score(Day 0 to Day 5)
- Efficacy : Rate of unplanned consultation or hospitalization for heart failure(Day 90)
- Efficacy : All-cause mortality(Day 90)
- Efficacy : All-cause mortality and Heart failure-related mortality(Day 90)
- Efficacy : Change in clinical congestion parameters(At Day 15)
- Efficacy : Change in NT-proBNP concentration(At Day 15)
- Safety : Change in serum sodium concentration(Day 0 to Day 5)
- Safety : Percentage of participants with serum sodium <125 mmol/L(Day 5)
- Safety: Incidence of acute kidney injury (KDIGO stage ≥2)(Day 0 to Day 5)
- Safety : Change in serum potassium concentration(Day 0 to Day 5)
- Safety: Percentage of participants with serum potassium <2.5 mmol/L(Day 5)
- Safety: Change in serum bicarbonate concentration from Day 0 to Day 5(Day 0 to Day 5)
- Percentage of participants with serum bicarbonate <20 mmol/L(Day 5)
- Safety: Change in systolic blood pressure(Day 0 to Day 5)
- Safety: Percentage of participants with systolic blood pressure <90 mmHg(Day 0 to day 5)
- Safety: Incidence of low cardiac output or cardiogenic shock(Day 0 to Day 5)
- Safety: Hospitalization due to treatment failure or poor treatment tolerance(Day 5 and Day 15)
- Medicoeconomic: Hospital medical costs(Day 90)