Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001345-14
    Sponsor's Protocol Code Number:ZOLCAR17001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-001345-14
    A.3Full title of the trial
    A multi-center, randomized, double-blind, phase IV clinical trial on the diuretic effects of Acetazolamide (Diamox ®) in patients with Decompensated heart failure and Volume OveRload.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center, randomized, double-blind, phase IV clinical trial to investigate if therapy with Acetazolamide (Diamox®) improves diuretic efficacy in decompensated heart failure patients to allow for a better/faster decongestion.
    A.3.2Name or abbreviated title of the trial where available
    Acetazolamide (Diamox ®) in Decompensated heart failure with Volume OveRload (ADVOR)
    A.4.1Sponsor's protocol code numberZOLCAR17001
    A.5.4Other Identifiers
    Name:Clinical trials.gov NumberNumber:NCT03505788
    Name:KCE Trial NumberNumber:KCE-17001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorZiekenhuis Oost-Limburg Autonome Verzorgingsinstelling
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBelgian Health Care Knowledge Centre (KCE)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZiekenhuis Oost-Limburg, Autonome Verzorgingsinstelling
    B.5.2Functional name of contact pointTrial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressSchiepse Bos 6
    B.5.3.2Town/ cityGenk
    B.5.3.3Post code3600
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3289327191
    B.5.6E-mailadvor@zol.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Diamox
    D.2.1.1.2Name of the Marketing Authorisation holderMercury Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study population will consist of patients hospitalized with decompensated heart failure and demonstrating at least one clinical sign of volume overload.
    E.1.1.1Medical condition in easily understood language
    A sudden worsening of signs and symptoms of heart failure. In this specific study population with clinical symptoms of fluid retention.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019284
    E.1.2Term Heart failure, congestive
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate if combination therapy with acetazolamide improves loop diuretic efficacy to increase diuresis in decompensated heart failure (HF) patients, allowing for a better/faster decongestion and potentially resulting in improved clinical outcome and increased quality of life.
    E.2.2Secondary objectives of the trial
    - Combined end-point of all-cause mortality and heart failure readmission during 3 months of follow-up
    - Length of index hospital admission
    - Longitudinal changes in EuroQoL five dimensions questionnaire (EQ-5D) (baseline, the morning of day 4, any readmission, and 3 months).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Laboratory sub-study included in the protocol of the main study version 1.0
    E.3Principal inclusion criteria
    - An elective or emergency hospital admission with clinical diagnosis of ADHF and at least one clinical sign of volume overload (e.g. oedema, ascites or pleural effusion)
    - Maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide or 40 mg furosemide or 20 mg torsemide for at least 1 month before hospital admission
    - Plasma NT proBNP levels >1000 ng/mL or BNP levels >250 ng/mL at screening
    E.4Principal exclusion criteria
    - Concurrent diagnosis of an acute coronary syndrome defined as typical chest pain in addition to a troponin rise above the 99th percentile and/or electrocardiographic changes suggestive of cardiac ischemia
    - A previous or current diagnosis of hypertrophic, restrictive, or constrictive cardiomyopathy as documented in the medical record
    - History of congenital heart disease requiring surgical correction
    - History of cardiac transplantation and/or ventricular assist device
    - Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg at the moment of admission
    - Expected use of intravenous inotropes, vasopressors or nitroprusside during the study. Use of nitrates is allowed only if the patient’s systolic blood pressure is >140 mmHg
    - Estimated glomerular filtration rate (eGFR) <20 mL/min/1.73m² at screening
    - Use of renal replacement therapy or ultrafiltration at any time before study inclusion
    - Treatment with intravenous loop diuretics > 2 mg bumetanide during the index hospitalization before randomization
    - Treatment with acetazolamide during the index hospitalization before randomization
    - Exposure to nephrotoxic agents (i.e. contrast dye) anticipated within the next 3 days
    - Use of any non-protocol defined diuretic agent with the exception of mineralocorticoid receptor antagonists. Thiazides, metolazone, indapamide and amiloride should be stopped upon study inclusion. If patient is taking a combination drug including a thiazide-type diuretic, the thiazide-type diuretic should be stopped upon study inclusion.
    - Current use of sodium-glucose transporter 2 inhibitors
    - Subjects who are pregnant or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Treatment success (decongestion achieved) on the morning of day 4 without the need for escalating diuretic strategy (doubling loop diuretic dose, addition of chlorthalidone, or ultrafiltration) on the morning of day 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    morning of study day 4
    E.5.2Secondary end point(s)
    - Combined end-point of all-cause mortality and heart failure readmission during 3 months of follow-up
    - Length of index hospital admission
    - Longitudinal changes in EuroQoL five dimensions questionnaire (EQ-5D) (baseline, the morning of day 4, any readmission, and 3 months).
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 4, hospital submission and 3 months after study start
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned24
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 129
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 390
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state519
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-27
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 08 21:42:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA