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    Summary
    EudraCT Number:2020-005484-31
    Sponsor's Protocol Code Number:20-197
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-005484-31
    A.3Full title of the trial
    SPironolactONe for the maintenance of Sinus Rhythm in hypertensive patients with atrial fibrillation and preserved left ventricular ejection fraction: a Prospective Randomized Open Blinded End-point (PROBE) multicenter study (SPONSoR study).
    SPIRONOLACTONE POUR LE MAINTIEN D’UN RYTHME SINUSAL EN PREVENTION DES RECIDIVES DE FIBRILLATION ATRIALE CHEZ LES PATIENTS HYPERTENDUS ET AVEC UNE FRACTION D’EJECTION VETRICULAIRE CONSERVEE (SPONSOR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SPIRONOLACTONE POUR LE MAINTIEN D’UN RYTHME SINUSAL EN PREVENTION DES RECIDIVES DE FIBRILLATION ATRIALE CHEZ LES PATIENTS HYPERTENDUS ET AVEC UNE FRACTION D’EJECTION VETRICULAIRE CONSERVEE (SPONSOR)
    SPIRONOLACTONE POUR LE MAINTIEN D’UN RYTHME SINUSAL EN PREVENTION DES RECIDIVES DE FIBRILLATION ATRIALE CHEZ LES PATIENTS HYPERTENDUS ET AVEC UNE FRACTION D’EJECTION VETRICULAIRE CONSERVEE (SPONSOR)
    A.3.2Name or abbreviated title of the trial where available
    SPONSoR
    SPONSoR
    A.4.1Sponsor's protocol code number20-197
    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 SponsorCHU CAEN Normandie
    B.1.3.4CountryFrance
    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 supportCHU CAEN Normandie
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU CAEN Normandie
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressCHU CAEN Normandie - service Pharmacologie
    B.5.3.2Town/ cityCAEN
    B.5.3.3Post code14033
    B.5.3.4CountryFrance
    B.5.4Telephone number33231064670
    B.5.6E-mailalexandre-j@chu-caen.fr
    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 SPIRONOLACTONE
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.1Product nameSPIRONOLACTONE
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertensive patients > 18 years referred for documented AF episodes (symptomatic or not) with preserved left ventricular ejection fraction (LVEF).
    Hypertensive patients > 18 years referred for documented AF episodes (symptomatic or not) with preserved left ventricular ejection fraction (LVEF).
    E.1.1.1Medical condition in easily understood language
    Hypertensive patients > 18 years referred for documented AF episodes (symptomatic or not) with preserved left ventricular ejection fraction (LVEF).
    Hypertensive patients > 18 years referred for documented AF episodes (symptomatic or not) with preserved left ventricular ejection fraction (LVEF).
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10020775
    E.1.2Term Hypertension arterial
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish whether administration of spironolactone (25 mg per day initially, titrated to a maximum of 50 mg per day) on top of standard therapy, leads to a reduction in the recurrence of documented AF episodes (symptomatic or not) occurring from randomization and within 12 months, compared with standard therapy alone, in hypertensive patients with preserved LVEF
    E.2.2Secondary objectives of the trial
    To evaluate whether spironolactone administration affects:
    - Symptomatic documented AF occurring from randomization and within 12 months,
    - The time of recurrence of the first documented AF episode (symptomatic or not), from randomization and within 12 months,
    - The cumulative recurrence rate of AF from randomization and within 12 months,
    - Major cardiovascular events and death (all-cause mortality, stroke, myocardial infarction, heart failure) occurring from randomization and within 12 months,
    - The rate of cerebral/systemic thrombo-embolic and bleeding events,
    - Mean ventricular rate at the recurrence of AF,
    - Blood pressure reduction and control,
    - Safety parameters, particularly blood pressure, serum potassium levels and renal function from randomization and within 12 months.
    - To constitute a biobank for future ancillary studies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female; Age > 18 years
    Hypertension defined as current use of anti-hypertensive drugs for more than 12 months
    Paroxysmal or no long-standing persistent AF (as defined by the ESC guidelines) with at least 1 episode within the preceding 6 months
    Sinus rhythm at enrolment
    Patient signed consent
    Willing to comply with scheduled visits, as outlined in the protocol
    French speaking
    Recipients of the social security regime
    E.4Principal exclusion criteria
    Contraindications to spironolactone therapy: intolerance, hyperkalemia (>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1,73m² (per the CKD-EPI equation). Subjects with serum creatinine ≥2.5 mg/dl are also excluded even if their eGFR is ≥30 ml/min/1,73m²), Severe liver dysfunction.
    Patients already treated by other potassium sparing medication (amiloride, triamterene) or MRA (spironolactone, eplerenone, potassium canreonate, finerenone).
    Other MRAs indication: aldosteronism, heart failure, cirrhosis ascites, nephrotic syndrome, myasthenia
    LVEF < 40% obtained within 6 months prior to V0
    Planned atrial fibrillation ablation within 6 months after randomization
    Moderate-to-severe valvular heart disease
    Permanent AF or long-standing persistent AF as defined by the ESC guidelines
    AF on the ECG at the inclusion visit
    Previous left atrial ablation or previous maze or maze-like surgery
    Acute, reversible or secondary AF (infection, hyperthyroidism, pericarditis or myocarditis)
    Left atrium diameter > 60 mm obtained within 6 months prior to V0
    Contraindication to oral anticoagulation therapy
    Patients with persistent bradycardia of less than 50 beats per minute, a PR interval of 0.2 second or more on ECG, second degree (or higher) atrioventricular block, and snus-node disease without an implanted pacemaker
    Hemodynamic instability and unstable conditions: angina or acute coronary syndrome or heart failure during the last 3 months, cardiogenic shock
    A life expectancy of 1 years or less
    Patients included or planning to be included in another medical research protocol whose pharmacological and scientific rationales might interfere with the Sponsor trial
    Patients unable to complete the protocol follow-up
    Pregnant or nursing women
    Adults with protective measures (curatorship or tutorship) and vulnerable patients
    E.5 End points
    E.5.1Primary end point(s)
    First documented recurrence of AF occurring from randomization and within 12 months, defined as an episode lasting for at least 30 sec documented on 12-leads ECG (planned or not) or on extended holter monitor (Cardioskin Lite®, Bioserenity, Inc.).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 mois
    E.5.2Secondary end point(s)
    12 mois
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other No
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 580
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 580
    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 Yes
    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 state580
    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)
    suivi classique
    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 Decision2022-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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