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    Summary
    EudraCT Number:2022-003884-37
    Sponsor's Protocol Code Number:RONIN-CCV
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-003884-37
    A.3Full title of the trial
    Role of inhaled nitric oxide on right ventricular function and pulmonary vascular mechanics following cardiac surgery
    Papel del óxido nítrico inhalado en la función ventricular derecha y la mecánica vascular pulmonar tras la cirugía cardiaca
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of inhaled nitric oxide on right ventricular function and pulmonary vascular mechanics following cardiac surgery
    Papel del óxido nítrico inhalado en la función ventricular derecha y la mecánica vascular pulmonar tras la cirugía cardiaca
    A.4.1Sponsor's protocol code numberRONIN-CCV
    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 SponsorFernando Suarez Sipmann
    B.1.3.4CountrySpain
    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 supportFernando Suarez Sipmann
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFernando Suarez Sipmann
    B.5.2Functional name of contact pointFernando Suarez Sipmann
    B.5.3 Address:
    B.5.3.1Street AddressCalle Diego de León 62
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number+34915202200
    B.5.6E-mailfsuarez@salud.madrid.org
    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 Vasokinox
    D.2.1.1.2Name of the Marketing Authorisation holderAIR LIQUIDE SANTE INTERNATIONAL
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEndotracheopulmonary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNitric oxide
    D.3.9.2Current sponsor codeVasoKINOX
    D.3.9.4EV Substance CodeSUB12540MIG
    D.3.10 Strength
    D.3.10.1Concentration unit PPM part per million
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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
    Patients in the immediate cardiac surgery post-operative period
    Pacientes en el postoperatorio inmediato de cirugía cardiaca
    E.1.1.1Medical condition in easily understood language
    Patients in the immediate cardiac surgery post-operative period
    Pacientes en el postoperatorio inmediato de cirugía cardiaca
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effects of inhaled iNO on pulmonary vascular mechanics, right ventricular function, and right ventricular-vascular coupling in patients in the immediate cardiac surgery post-operative period
    Estudiar los efectos del iNO inhalado sobre la mecánica vascular pulmonar, la función ventricular derecha y el acoplamiento ventrículo-vascular derecho en pacientes en el postoperatorio inmediato de cirugía cardiaca
    E.2.2Secondary objectives of the trial
    - To evaluate the synergistic effects of iNO with a lung recruitment maneuver, on pulmonary vascular mechanics, right ventricular function, and right ventricular-vascular coupling in the immediate post-operative period after cardiac surgery

    - To study patterns of pulmonary blood flow redistribution measured by EIT predictive of a positive effect on vascular mechanics and right ventricular function.
    - Evaluar los efectos sinérgicos del iNO con una maniobra de reclutamiento pulmonar sobre la mecánica vascular pulmonar, la función ventricular derecha y el acoplamiento ventrículo-vascular derecho en el postoperatorio inmediato de cirugía cardiaca.

    - Estudiar los patrones de redistribución del flujo sanguíneo pulmonar medidos mediante TIE predictivos de un efecto positivo sobre la mecánica vascular y la función ventricular derecha.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Obtained informed consent
    - Age > 18 years
    - Under passive mechanical ventilation
    - Pre-operative FEVI ≥ 30%
    - Absence of hypovolemia: absence of ventricular "kissing" and / or superior vena cava collapsibility index < 20%
    - Stable spontaneous heart rythm
    - Post-operative hemodynamic stability
    - Mean arterial pressure ≥ 60 mmHg
    - PVC ≥ 10 mmHg
    - HR ≤ 100 bpm without tachyarrhythmias
    - Lactic acid ≤ 3 mmol/L
    - Single vasoconstrictor treatment
    - Norepinephrine dose ≤ 0.2 g/kg/min, without an increase ≥ 15% in the previous 30 min
    - Consentimiento informado obtenido
    - Edad > 18 años
    - Bajo ventilación mecánica pasiva
    - FEVI preoperatorio ≥ 30%.
    - Ausencia de hipovolemia: ausencia de "kissing" ventricular y/o índice de colapsibilidad de la vena cava superior < 20%.
    - Ritmo cardiaco espontáneo estable
    - Estabilidad hemodinámica postoperatoria:
    - Presión arterial media ≥ 60 mmHg
    - PVC ≥ 10 mmHg
    - FC ≤ 100 lpm sin taquiarritmias
    - Ácido láctico ≤ 3 mmol/L
    - Tratamiento vasoconstrictor único
    - Dosis de norepinefrina ≤ 0,2 g/kg/min, sin un aumento ≥ 15% en los 30 min previos
    E.4Principal exclusion criteria
    - Cor pulmonale or presence of preoperative pulmonary vascular pathology
    - Chronic pulmonary hypertension (mPAP> 35 mmHg) related to advanced COPD or chronic thromboembolic disease
    - Surgery involving the tricuspid or pulmonary valves.
    - Intra- or post-operative use of nitroprusside or nitroglycerine
    - Pre-operative dependence of inotropic drugs or vasoconstrictors
    - Use of levosimendan. If dobutamine is in use, patients can be included provided the infusion can be stopped or is ≤ 1 µg/kg/min
    - Pacemaker dependency
    - Cor pulmonale o presencia de patología vascular pulmonar preoperatoria
    - Hipertensión pulmonar crónica (PAPm> 35 mmHg) relacionada con EPOC avanzada o enfermedad tromboembólica crónica
    - Cirugía que afecte a las válvulas tricúspide o pulmonar
    - Uso intra o postoperatorio de nitroprusiato o nitroglicerina
    - Dependencia preoperatoria de fármacos inotrópicos o vasoconstrictores
    - Uso de levosimendán. Si se utiliza dobutamina, los pacientes pueden incluirse siempre que la infusión pueda interrumpirse o sea ≤ 1 µg/kg/min
    - Dependencia de marcapasos
    E.5 End points
    E.5.1Primary end point(s)
    - Parameters of right ventricular function
    - Parámetros de la función ventricular derecha evaluados mediante ecocardiograma transefágico
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes
    30 minutos
    E.5.2Secondary end point(s)
    - Results of the electrical impedance tomography (EIT): regional distribution of ventilation and perfusion and EIT pulsatility
    - Resultados de la tomografia por impedancia eléctrica (IET): distribución regional de la ventilación y la perfusión y pulsatilidad del IET
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 minutes
    30 minutos
    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 No
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento estándar
    Standard treatment
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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
    LVLP
    UVUP
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state50
    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)
    Patient will be managed according to the routine clinical protocol
    El paciente será manejado según el protocolo clínico rutinario
    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 Decision2023-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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