Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Congenital heart defects

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   44336   clinical trials with a EudraCT protocol, of which   7366   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
     
    33 result(s) found for: Congenital heart defects. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2010-019713-21 Sponsor Protocol Number: CS/2007/2678 Start Date*: 2010-06-17
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: A RANDOMISED CONTROLLED TRIAL TO COMPARE NORMOXIC VERSUS STANDARD CARDIOPULMONARY BYPASS IN CYANOTIC CHILDREN UNDERGOING CARDIAC SURGERY
    Medical condition: The study investigates reoxygenation injury in cyanotic paediatric patients undergoing on-pump cardiac surgery. The types of heart condition being investigated result in chronic low blood oxygen sa...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10010395 Congenital cardiac malpositions and transpositions HLT
    12.1 10010397 Congenital cardiac structural defects NEC HLT
    12.1 10010396 Congenital cardiac septal defect NOS LLT
    12.1 10062326 Congenital cardiac septal defect LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004322-28 Sponsor Protocol Number: P120910 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10062326 Congenital cardiac septal defect LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-007042-18 Sponsor Protocol Number: CHD Vasovist Start Date*: 2007-03-08
    Sponsor Name:Kings College London [...]
    1. Kings College London
    2. Guy's & St Thomas'NHS Foundation Trust
    Full Title: Improved Diagnosis of Congenital Heart Disease by MRI using Vasovist - CHD Vasovist
    Medical condition: Congenital Heart Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010495 Congenital heart disease NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005507-89 Sponsor Protocol Number: 191190 Start Date*: 2016-08-15
    Sponsor Name:Department of Cardio-Thoracic and Vascular Surgery, Aarhus University Hospital
    Full Title: The pulmonary effect of bronchodilation on adult VSD patients with persistent or surgically corrected VSD
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10047298 Ventricular septal defect PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2007-000390-31 Sponsor Protocol Number: HyperHAES-PÄD-CARDIO-02 Start Date*: 2007-10-30
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Application of hypertonic hyperoncotic solutions for improvement of cardiac output after open heart surgery in children - monocentric, randomised, placebo controlled, double-blind clinical trial (p...
    Medical condition: Children after open-heart surgery for congenital cardiac disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019273 Heart disease congenital LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003325-10 Sponsor Protocol Number: 1.01 Start Date*: 2012-08-10
    Sponsor Name:VU University Medical Center
    Full Title: A randomized controlled trail on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth
    Medical condition: congenital anomalies
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10004953 Birth premature LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10007607 Cardiac septal defects congenital HLT
    14.1 10010331 - Congenital, familial and genetic disorders 10041524 Spina bifida PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002427-28 Sponsor Protocol Number: CIT-003-01 Start Date*: 2018-10-24
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-citrulline for the Prevention of Clinical Sequelae of Acut...
    Medical condition: Post-operative pulmonary dysfunction induced by cardiopulmonary bypass in pediatric subjects undergoing surgery for congenital heart defects.
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001759-38 Sponsor Protocol Number: K675 Start Date*: 2019-12-04
    Sponsor Name:Ruprecht-Karls University Heidelberg Medical Faculty, University Hospital represented in law by its commercial director
    Full Title: Pharmacokinetics of a microdosed cocktail containing rivaroxaban, apixaban and edoxaban in children with congenital heart defects
    Medical condition: 20 children with non-cyanotic congenital heart defects especially atrial septal defects (ASD) and ventricular septal defects (VSD) in admitted to the paediatric cardiology wards will be included. T...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-004684-12 Sponsor Protocol Number: iNO_Protocol_V1.1_16.07.17 Start Date*: 2019-05-16
    Sponsor Name:Lady Cilento Children's Hospital
    Full Title: Nitric Oxide during Cardio Pulmonary Bypass during surgery for congenital heart defects: A Randomised Controlled Trial.
    Medical condition: Congenital heart disease ranks still within the top causes of infant mortality in industrialized countries. Despite considerable advances over the past decade, the exposure to cardiopulmonary bypas...
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-000946-38 Sponsor Protocol Number: EFC5314 Start Date*: 2007-01-24
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: International randomized double blind clinical study evaluating the efficacy and safety of clopidogrel 0.2mg/kg once daily versus placebo in neonates and infants with cyanotic congenital heart dise...
    Medical condition: Neonates or infants (age less than or equal to 92 days at the time of randomization) with systemic to pulmonary arterial shunt for palliation of cyanotic congenital heart disease.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019273 Heart disease congenital LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) FI (Completed) SE (Completed) DK (Completed) PT (Completed) FR (Completed) HU (Completed) IT (Completed) NL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003995-65 Sponsor Protocol Number: TAKICARD-1 Start Date*: 2015-11-25
    Sponsor Name:Västra Götalandsregionen, Sahlgrenska University Hospital /Queen Silvia children's hospital
    Full Title: Pharmacokinetics of ANP, a diuretic hormone, in neonates undergoing surgery for congenital heart defects. A pilot study.
    Medical condition: Acute renal failure after heart surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038359 - Renal and urinary disorders 10038447 Renal failure neonatal PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005440-98 Sponsor Protocol Number: Start Date*: 2012-04-12
    Sponsor Name:AKH Linz
    Full Title: Double blinded randomised trial for the evaluation of the effectiveness of prophylactic use of sildenafil for the prevention of pulmonary hypertensive crisis after congenital heart surgery
    Medical condition: Ventriculs septal defect, atrioventricular canal with pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10010401 Congenital cardiovascular anomaly therapeutic procedures HLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002131-34 Sponsor Protocol Number: GS-US-357-1394 Start Date*: 2015-05-07
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and ...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NL (Completed) ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020209-33 Sponsor Protocol Number: 07052010 Start Date*: 2010-10-12
    Sponsor Name:University Hospitals Leuven
    Full Title: BOsentan for Mild Pulmonary vascular disease in Asd patients (the BOMPA trial): a double-blind, randomized controlled, pilot trial
    Medical condition: Repaired (after the age of 40) atrial septal defect patients older than 40 years with evidence of mild pulmonary vascular disese as assessed by bicycle stress echocardiography.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003664 Atrial septal defect LLT
    12.1 10037400 Pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001835-20 Sponsor Protocol Number: OZBS12.15060 Start Date*: 2016-01-20
    Sponsor Name:Erasmus MC
    Full Title: Morphine intravenous vs. paracetamol intravenous after cardiac surgery in neonates and infants.
    Medical condition: congenital cardiac defects
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004815-29 Sponsor Protocol Number: ULA03 Start Date*: 2021-08-04
    Sponsor Name:Cardiorentis AG
    Full Title: Open-label, dose escalation study of ularitide for the investigation of hemodynamic effects in patients with pulmonary arterial hypertension (UPAH)
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000221-39 Sponsor Protocol Number: M15-539 Start Date*: 2017-12-14
    Sponsor Name:AbbVie Inc
    Full Title: A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infectio...
    Medical condition: Severe Respiratory Syncytial Virus (RSV) Infection
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-003335-33 Sponsor Protocol Number: AC-055-305 Start Date*: 2013-02-27
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome.
    Medical condition: Eisenmenger Syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10058554 Eisenmenger's syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) BG (Completed) BE (Completed) DE (Completed) PT (Completed) NL (Completed) AT (Completed) ES (Completed) HU (Completed) CZ (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2009-011150-17 Sponsor Protocol Number: AMB112565 Start Date*: 2010-08-26
    Sponsor Name:GlaxoSmithKline R&D Ltd
    Full Title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary arterial hypotension
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Completed) BE (Completed) SE (Completed) GB (Completed) AT (Completed) GR (Completed) DE (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-007455-26 Sponsor Protocol Number: GS-US-235-0101 Start Date*: 2010-01-21
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells i...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) DE (Prematurely Ended) BE (Prematurely Ended) GB (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    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-Sat May 17 15:20:12 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA