Achieve - ACetazolamide in patients with Heart failure, to decrease weight and relIEVE symptoms

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Montpellier

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-06-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess at day 5 the effectiveness of acetazolamide added to conventional treatment on decongestion (interventional group) compared to standard treatment (control group) in patients with ambulatory HF previously treated with furosemide (with fraction of left ventricular ejection impaired or not) and monitored by remote monitoring

Secondary objectives 10

1. To assess the effectiveness of acetazolamide added to conventional treatment in ambulatory HF patients monitored via telemonitoring as compared with conventional treatment on Decongestion during the first 5 days
2. To assess the effectiveness of acetazolamide added to conventional treatment in ambulatory HF patients monitored via telemonitoring as compared with conventional treatment on diuretic effectiveness on D5
3. To assess the effectiveness of acetazolamide added to conventional treatment in ambulatory HF patients monitored via telemonitoring as compared with conventional treatment on evolution of NtproBNP between D0 and D5
4. To assess the effectiveness of acetazolamide added to conventional treatment in ambulatory HF patients monitored via telemonitoring as compared with conventional treatment on quality of life and dyspnea during the first 5 days
5. To assess the effectiveness of acetazolamide added to conventional treatment in ambulatory HF patients monitored via telemonitoring as compared with conventional treatment on need for emergent/unplanned consultation or hospitalization for acute HF at day 90
6. Describe clinical (weight, VAS dyspnea, BP, HR, RHF and LHF signs) and biological (NtproBNP) decongestion evolution between D5 and D15 (in percentage)
7. Describe clinical (weight, VAS dyspnea, BP, HR, RHF and LHF signs) and biological (NtproBNP) decongestion evolution at D15
8. Evaluation and comparison of the occurrence of complications and adverse effects in the two groups at Day 5 (in particular: hyponatremia, acute renal failure, hypokalemia, metabolic acidosis, arterial hypotension, low cardiac output/cardiogenic shock)
9. Need for hospitalization for treatment failure or poor tolerance on D5 and D15
10. Comparison of hospital medical costs at D90 between the two groups studied (Health economic objective)

Conditions and MedDRA coding

Heart failure

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥ 18
2. Known HF with impaired, midly-reduced or preserved LVEF
3. Under guideline directed medical therapy for HF according to ESC Heart Failure Guidelines applicable at inclusion
4. Previously followed (or included at hospital discharge) by remote monitoring allowing daily weight by connected scale (i.e. Careline®, Optified-self®, NewCard®, Implicity®)
5. Under furosemide diuretic treatment ≥ 20mg/day for at least 30 days prior to inclusion
6. Current unplanned hospitalization or unplanned/emergent consultation for acute/decompensation HF

Exclusion criteria 21

1. Subject unable to express their consent and sign informed consent form
2. Chronic ventricular assist device or heart transplant patients
3. Acute heart failure from recent acute coronary syndrome (< 1 month)
4. Severe chronic renal failure or dialysis (GFR < 20 ml/min)
5. History of renal colic, hyperchloremic acidosis and wheat allergy (other than coeliac disease)
6. 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
7. Intolerance to sulphonamides
8. Hypersensitivity to the active substance (Acetazolamide) or to any of the excipients (Calcium carbonate, wheat starch, gelatine, magnesium stearate)
9. Concomitant use of carbamazepine or quinidinics (hydroquinidine, quinidine)
10. Low cardiac output syndrome/cardiogenic shock
11. Current use of acetazolamide or any other carbonic anhydrase inhibitor, including but not limited to topical ophthalmic formulations (e.g., brinzolamide, dorzolamide, methazolamide)
12. Subject not covered by public health insurance
13. Refusal to participate (absence of informed consent)
14. Subject under guardianship, legal protection, or deprived of liberty
15. Pregnant or breastfeeding women
16. Subject under law protection and prisoners
17. 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)
18. Subject unable to comprehend or adhere to the protocol and follow-up
19. Concurrent participation in another interventional study
20. Concomitant use of lithium, valproic acid and valpromide
21. Current use of high-dose aspirin (>300 mg/day)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of patients with weight loss > 2kg on connected scale (Remote telemonitoring system) on D5 in each of the two groups (experimental vs control)

Secondary endpoints 9

1. Percentage of weight variation between D0 and D5
2. Diuretic effectiveness on D5 calculated by calculating natriuresis corrected by mg of furosemide equivalence from the urinary ionogram performed on D5
3. Evolution of NtproBNP between D0 and D5
4. Evolution of the EQ-5D-5L value between D0 and D5
5. Evolution of the VAS score for dyspnea between D0 and D5
6. Rate of unplanned/emergency consultation or hospitalization for HF at D90
7. Rate of deaths from all causes or for HF at D90
8. Evolution of clinical (weight, VAS dyspnea, BP, HR, RHF and LHF signs) and biological (NtproBNP) between D5 and D15
9. Evolution of clinical (weight, VAS dyspnea, BP, HR, RHF and LHF signs) and biological (NtproBNP) at D15

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Montpellier

Sponsor organisation

Centre Hospitalier Universitaire De Montpellier

Address

191 Avenue Du Doyen Gaston Giraud

City

Montpellier Cedex 5

Postcode

34295

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Montpellier

Contact name

François ROUBILLE

Public contact point

Organisation

Centre Hospitalier Universitaire De Montpellier

Contact name

Sylvie GRANDEMANGE

Locations

1 EU/EEA country · 25 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications