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Clinical trials for Congenital Heart Defect

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
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    The EU Clinical Trials Register currently displays   44379   clinical trials with a EudraCT protocol, of which   7391   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 ).  
     
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    51 result(s) found for: Congenital Heart Defect. Displaying page 1 of 3.
    1  2  3  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: 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: 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: 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: 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: 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: 2016-003495-53 Sponsor Protocol Number: NL59009.018.16 Start Date*: 2016-11-29
    Sponsor Name:Academic Medical Center - Cardiology
    Full Title: Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease
    Medical condition: Pulmonary arterial hypertension related to congenital heart disease.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004411-31 Sponsor Protocol Number: AC-055-308 Start Date*: 2013-02-01
    Sponsor Name:ACTELION PHARMACEUTICALS LTD.
    Full Title: Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome.
    Medical condition: Eisenmenger Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10058554 Eisenmenger's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) BG (Completed) GB (Completed) DE (Completed) AT (Completed) PT (Completed) ES (Completed) HU (Completed) CZ (Completed) RO (Completed) PL (Completed) GR (Completed)
    Trial results: View results
    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: 2007-002774-64 Sponsor Protocol Number: HP 3.1 Start Date*: 2007-12-04
    Sponsor Name:Deutsches Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler
    Full Title: Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients
    Medical condition: Patients with pre-existing congenital heart disease may develop Eisenmenger physiology (EP), characterized by development of pulmonary arterial hypertension and intracardiac right to left shunt. Th...
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-004705-26 Sponsor Protocol Number: CRO529 Start Date*: 2007-05-10
    Sponsor Name:Imperial College London
    Full Title: Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology
    Medical condition: Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058554 Eisenmenger's syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-001187-21 Sponsor Protocol Number: SCRM-001 Start Date*: 2011-11-28
    Sponsor Name:University of Zurich
    Full Title: A Phase I/II, Open Monocentric Study To Evaluate The Safety And Efficacy Of An Autologous Tissue-Engineered Vascular Graft In Peadiatric Patients Requiring Reconstruction Of Right Ventricle Outflow...
    Medical condition: functional single ventricle physiology functional single left ventricle functional single right ventricle functional single biventricle
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10040729 Single ventricle LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    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: 2022-000608-36 Sponsor Protocol Number: UKER-MFHO-01 Start Date*: 2022-11-07
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Prospective, randomized, controlled, open, multicenter clinical trial on the efficacy and safety of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy to treat underdevel...
    Medical condition: underdeveloped left ventricular structures in human fetus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10021076 Hypoplastic left heart syndrome PT
    Population Age: In utero, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    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: 2019-002533-11 Sponsor Protocol Number: AC-055-315 Start Date*: 2020-06-17
    Sponsor Name:ACTELION Pharmacteuticals Ltd.
    Full Title: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Toler...
    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 (Ongoing) CZ (Trial now transitioned) HU (Trial now transitioned) SE (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) BE (Trial now transitioned) NO (Completed) SK (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) BG (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003181-12 Sponsor Protocol Number: HOTPOT1 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000137-31 Sponsor Protocol Number: 2017-2019 Start Date*: 2017-12-19
    Sponsor Name:VU University Medical Center
    Full Title: Pulmonary Hypertension REversal in Clusters of Patients With Identical Pathobiological Substrates. 6-Mercaptopurine Proof-of-Concept Trial
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037454 Pulmonary vascular disorders HLGT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037401 Pulmonary hypertensions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002448-10 Sponsor Protocol Number: BIA-51058-201 Start Date*: 2018-10-31
    Sponsor Name:Bial - Portela & Ca, S.A.
    Full Title: An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH)
    Medical condition: Pulmonary arterial hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) PT (Completed) ES (Ongoing) GB (Temporarily Halted) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003482-68 Sponsor Protocol Number: BAY 63-2521/12934 Start Date*: 2008-11-26
    Sponsor Name:Bayer HealthCare AG
    Full Title: Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptom...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IE (Prematurely Ended) AT (Completed) ES (Completed) NL (Completed) FR (Completed) SE (Completed) GB (Completed) CZ (Completed) DK (Completed) BE (Completed) IT (Completed) PT (Completed) GR (Completed)
    Trial results: View results
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