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

2026년 8월 13일 업데이트: University Hospital, Montpellier

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

366

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
      • Amiens, 프랑스
        • University Hospital Amiens-Picardie
        • 연락하다:
        • 수석 연구원:
          • Emmanuelle VERMES, MD
      • Angers, 프랑스
        • University Hospital Angers
        • 연락하다:
        • 수석 연구원:
          • Sylvain Grall, MD
      • Avignon, 프랑스
        • Avignon Hospital
        • 수석 연구원:
          • Stephane Andrieu, MD
        • 연락하다:
      • Besançon, 프랑스
        • University Hospital Besançon
        • 수석 연구원:
          • Marie France Seronde, MD
        • 연락하다:
      • Bordeaux, 프랑스
        • University Hospital Bordeaux
        • 연락하다:
        • 수석 연구원:
          • Sylvain Ploux, MD
      • Brest, 프랑스
        • University Hospital Brest
        • 연락하다:
        • 수석 연구원:
          • Ombeline Paglia, MD
      • Béziers, 프랑스
        • Hospital Beziers
        • 연락하다:
        • 수석 연구원:
          • Frederic Georger, MD
      • Caen, 프랑스
        • University Hospital Caen
        • 연락하다:
        • 수석 연구원:
          • Laurent Herrou, MD
      • Chartres, 프랑스
        • Chartres Hospital
        • 연락하다:
        • 수석 연구원:
          • Franck Albert, MD
      • Cholet, 프랑스
        • Cholet Hospital
        • 연락하다:
        • 수석 연구원:
          • Thi-thanh-hien Pham, MD
      • Corbeil-Essonnes, 프랑스
        • Sud Francilien Hospital
        • 연락하다:
        • 수석 연구원:
          • Fatiha Ait Yahia, MD
      • Dreux, 프랑스
        • Dreux Hospital
        • 연락하다:
        • 수석 연구원:
          • Dario BOTTIGLIERO, MD
      • Grenoble, 프랑스
        • University Hospital Grenoble Alpes
        • 연락하다:
        • 수석 연구원:
          • Muriel Salvat, MD
      • Grenoble, 프랑스
        • Cardiovascular Institute - Grenoble Mutualist Hospital Group
        • 연락하다:
        • 수석 연구원:
          • Benjamin CASEZ, MD
      • Le Kremlin-Bicêtre, 프랑스
        • Bicetre Hospital
        • 연락하다:
        • 수석 연구원:
          • Emmanuelle Berthelot, MD
      • Le Mans, 프랑스
        • Pôle Santé Sud - Le Mans
        • 연락하다:
        • 수석 연구원:
          • Christophe Bachelet, MD
      • Lyon, 프랑스
        • Louis Pradel Hospital
        • 연락하다:
        • 수석 연구원:
          • Nathan Mewton, MD
      • Montpellier, 프랑스
        • University hospital Montpellier
        • 수석 연구원:
          • François Roubille, MD
        • 연락하다:
      • Nancy, 프랑스
        • Regional University Hospital Nancy
        • 수석 연구원:
          • Nicolas Girerd, MD
        • 연락하다:
      • Nantes, 프랑스
        • The Confluent Private Hospital
        • 연락하다:
        • 수석 연구원:
          • Nicolas Jacob, MD
      • Nîmes, 프랑스
        • University Hospital Nîmes
        • 연락하다:
        • 수석 연구원:
          • Elvira Prunet, MD
      • Strasbourg, 프랑스
        • Ellipse Center Strasbourg
        • 연락하다:
        • 수석 연구원:
          • Florian Zores, MD
      • Toulon, 프랑스
        • Sainte Musse Hospital Toulon
        • 연락하다:
        • 수석 연구원:
          • Jean-Michel TARTIERE, MD
      • Toulouse, 프랑스
        • University Hospital toulouse
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Romain ITIER
        • 부수사관:
          • Clément DELMAS, MD
      • Valenciennes, 프랑스
        • Valenciennes Hospital
        • 연락하다:
        • 수석 연구원:
          • Thomas Mercier, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.
의약품: Acetazolamide
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.
활성 비교기: 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.
의약품: Furosemide
Standard treatment with loop diuretics (furosemide) administered for up to 5 days according to standard clinical practice.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of participants with weight loss >2 kg at Day
기간: 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.
Day 5

2차 결과 측정

결과 측정
측정값 설명
기간
Efficacy : Percentage of weight variation
기간: 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.
Day 0 to Day 5
Efficacy : Diuretic effectiveness
기간: 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.
Day 5
Efficacy : Change in NT-proBNP concentration
기간: Day 0 to Day 5
Change in plasma NT-proBNP concentration measured from blood samples between baseline and Day 5.
Day 0 to Day 5
Efficacy : Change in health-related quality of life (EQ-5D-5L)
기간: 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).
Day 0 to Day 5
Efficacy : Change in dyspnea Visual Analogue Scale (VAS) score
기간: 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).
Day 0 to Day 5
Efficacy : Rate of unplanned consultation or hospitalization for heart failure
기간: Day 90
Percentage of participants requiring an unplanned medical consultation, emergency department visit, or hospitalization for heart failure
Day 90
Efficacy : All-cause mortality
기간: Day 90
Percentage of participants who die from any cause.
Day 90
Efficacy : All-cause mortality and Heart failure-related mortality
기간: Day 90
Percentage of participants who die any cause or from heart failure during follow-up.
Day 90
Efficacy : Change in clinical congestion parameters
기간: 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.
At Day 15
Efficacy : Change in NT-proBNP concentration
기간: At Day 15
Change in plasma NT-proBNP concentration measured on blood samples collected after the acute treatment period.
At Day 15
Safety : Change in serum sodium concentration
기간: 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.
Day 0 to Day 5
Safety : Percentage of participants with serum sodium <125 mmol/L
기간: Day 5
Percentage of participants presenting severe hyponatremia, defined as a serum sodium concentration below 125 mmol/L, on Day 5.
Day 5
Safety: Incidence of acute kidney injury (KDIGO stage ≥2)
기간: 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.
Day 0 to Day 5
Safety : Change in serum potassium concentration
기간: 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.
Day 0 to Day 5
Safety: Percentage of participants with serum potassium <2.5 mmol/L
기간: Day 5
Percentage of participants presenting severe hypokalemia, defined as a serum potassium concentration below 2.5 mmol/L, on Day 5.
Day 5
Safety: Change in serum bicarbonate concentration from Day 0 to Day 5
기간: 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.
Day 0 to Day 5
Percentage of participants with serum bicarbonate <20 mmol/L
기간: Day 5
Percentage of participants presenting serum bicarbonate concentrations below 20 mmol/L on Day 5.
Day 5
Safety: Change in systolic blood pressure
기간: Day 0 to Day 5
Assessment of the change in systolic blood pressure between baseline Day 0 and Day 5 during treatment.
Day 0 to Day 5
Safety: Percentage of participants with systolic blood pressure <90 mmHg
기간: Day 0 to day 5
Percentage of participants presenting systolic blood pressure below 90 mmHg during treatment.
Day 0 to day 5
Safety: Incidence of low cardiac output or cardiogenic shock
기간: Day 0 to Day 5
Percentage of participants developing low cardiac output syndrome or cardiogenic shock between D0 and D5.
Day 0 to Day 5
Safety: Hospitalization due to treatment failure or poor treatment tolerance
기간: Day 5 and Day 15
Percentage of participants requiring hospitalization because of treatment failure or poor treatment tolerance.
Day 5 and Day 15
Medicoeconomic: Hospital medical costs
기간: 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.
Day 90

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Montpellier

수사관

  • 연구 책임자: François ROUBILLE, MD, University Hospital, Montpellier

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2029년 1월 1일

연구 완료 (추정된)

2029년 1월 1일

연구 등록 날짜

최초 제출

2026년 7월 27일

QC 기준을 충족하는 최초 제출

2026년 7월 27일

처음 게시됨 (실제)

2026년 7월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 13일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RECHMPL24_0295
  • 2025-524344-35-00 (씨티스)

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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