Clinical trial • Phase III • Cardiology
Oxygen for Hypoplastic left heart syndrome
Phase III trial of Oxygen for Hypoplastic left heart syndrome. Randomised, open-label, none/not specified-controlled. 64 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Hypoplastic left heart syndrome
- Trial Stage
- Phase III
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 12-03-2024
- First CTIS Authorization Date
- 25-03-2024
Trial design
Randomised, open-label, none/not specified-controlled Phase III trial across 7 sites in Germany.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 64
Eligibility
Recruits 64 Vulnerable population selected. Pregnant women (mothers) and their unborn babies are included; mothers must be >= 18 years and thus provide informed consent. Subject information and informed consent form available (document L1_SIS_ICF_HYPEROX_redacted). No explicit assent process is described in the available record..
- Vulnerable Population
- Vulnerable population selected. Pregnant women (mothers) and their unborn babies are included; mothers must be >= 18 years and thus provide informed consent. Subject information and informed consent form available (document L1_SIS_ICF_HYPEROX_redacted). No explicit assent process is described in the available record.
Inclusion criteria
- {"criterion_text":"- >= 18 years of age (mother)\n- third trimester of pregnancy (mother)\n- non-smoker (mother)\n- A. uterina doppler ultrasound at least one-sided without pathological findings (mother)\n- cardiac disorder with at least one underdeveloped left ventricular structure detected by echocardiography (fetus)\n- sufficient fetal cardiac function (fetus)"}
Exclusion criteria
- {"criterion_text":"- alcohol or drug abuse (mother)\n- underlying disease or chromosomal abnormality which might influence the effect of MFHO (fetus)\n- hemodynamic factors with influence on filling/emptying of the left heart which might affect MFHO efficacy (fetus)\n- fetal cardiac failure (fetus)\n- Hydrops fetalis (fetus)\n- severe growth retardation (fetus)\n- no flow in A. umbilicalis (fetus)\n- severe extracardiac malformations (fetus)\n- visit 2: inadequate response to O2 provocation during echocardiography (fetus)\n- multiple pregnancy (mother)\n- adipositas permagna (BMI>40) (mother)\n- diabetes melllitus, insulin-dependent (mother)\n- obstetrical issues (e.g. Cervix uteri <25mm, premature contractions, preeclampsia, eclampsia, HELLP Syndrome, …) (mother)\n- fetus impossible to evaluate by echocardiography (mother)\n- patholog. utero-placental resistance (mother)\n- cardiac failure (NYHA III/IV or decompensated) (mother)\n- severe COPD, hypercapnia (mother)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- median change of the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures under O2 provocation at the time point PW35d0 (+/- 2 days) compared to the initial values on PW32d0 (+/- 2 days) under O2 provocation","definition_or_measurement_approach":"Measured as the median change of the sum of Z-scores of pre-specified echocardiographic fetal left heart structures under oxygen provocation, comparing measurements at PW35d0 (+/-2 days) versus baseline at PW32d0 (+/-2 days)."}
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 61
- Consent Approach
- Informed consent provided by the mother (must be >=18 years). Subject information and informed consent form available (document L1_SIS_ICF_HYPEROX_redacted). No details on assent or additional age-specific consent documents or languages are provided in the available record.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 64
Germany
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 749
- Number Of Sites
- 7
- Number Of Participants
- 64
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Kinder- und Jugendklinik
- Principal Investigator Name
- Holm Schneider
- Principal Investigator Email
- holm.schneider@uk-erlangen.de
- Contact Person Name
- Holm Schneider
- Contact Person Email
- holm.schneider@uk-erlangen.de
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Olgasptial / Frauenklinik
- Principal Investigator Name
- Ulrich Karck
- Principal Investigator Email
- frauenklinik@klinikum-stuttgart.de
- Contact Person Name
- Ulrich Karck
- Contact Person Email
- frauenklinik@klinikum-stuttgart.de
- Site Name
- Universitaet Leipzig
- Department Name
- Abteilung für Geburtsmedizin
- Principal Investigator Name
- Susanne Schrey-Petersen
- Principal Investigator Email
- susanne.schrey@medizin.uni-leipzig.de
- Contact Person Name
- Susanne Schrey-Petersen
- Contact Person Email
- susanne.schrey@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Frauenheilkunde und Geburtshilfe
- Principal Investigator Name
- Antonella Iannaccone
- Principal Investigator Email
- antonella.iannaccone@uk-essen.de
- Contact Person Name
- Antonella Iannaccone
- Contact Person Email
- antonella.iannaccone@uk-essen.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Deutsches Zentrum für Fetalchirurgie und minimal invasive Therapie (DZFT)
- Principal Investigator Name
- Thomas Kohl
- Principal Investigator Email
- thomas.kohl@umm.de
- Contact Person Name
- Thomas Kohl
- Contact Person Email
- thomas.kohl@umm.de
- Site Name
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
- Department Name
- Klinik für Kinderkardiologie und angeborene Herzfehler
- Principal Investigator Name
- Stephan Schubert
- Principal Investigator Email
- sschubert@hdz-nrw.de
- Contact Person Name
- Stephan Schubert
- Contact Person Email
- sschubert@hdz-nrw.de
- Site Name
- Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
- Department Name
- Klinik St. Hedwig - Klinik für Frauenheilkunde und Geburtshilfe
- Principal Investigator Name
- Angela Köninger
- Principal Investigator Email
- angela.koeninger@barmherzige-regensburg.de
- Contact Person Name
- Angela Köninger
- Contact Person Email
- angela.koeninger@barmherzige-regensburg.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Erlangen AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Third parties
- {"country":"Germany","full_name":"AIR LIQUIDE MEDICAL GMBH","duties_or_roles":"Marketing authorisation holder / manufacturer of LOX medicAL 100% (V/V) (product listed in trial documents)","organisation_type":"Company"}
Investigational products
- Investigational Product Name
- LOX medicAL 100% (V/V) Gas zur medizinischen Anwendung, kälteverflüssigt
- Active Substance
- Oxygen
- Modality
- Other
- Routes Of Administration
- INHALATION USE
- Route
- Inhalation
- Authorisation Status
- Authorised (marketing authorisation present in DE, marketingAuthNumber: 6283297.00.00)
- Maximum Dose
- 4320 l per day
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