211. Hypoplastic left heart syndrome Clinical trials / Disease details


Clinical trials : 22 Drugs : 29 - (DrugBank : 9) / Drug target genes : 5 - Drug target pathways : 14

  
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1NCT04925024
(ClinicalTrials.gov)
June 25, 20218/6/2021Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial.Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial.Hypoplastic Left Heart SyndromeBiological: Lomecel-B medicinal signaling cellsAnn & Robert H Lurie Children's Hospital of ChicagoNational Heart, Lung, and Blood Institute (NHLBI);The University of Texas Health Science Center, Houston;Longeveron Inc.RecruitingN/A12 MonthsAll38Phase 2United States
2NCT04181255
(ClinicalTrials.gov)
February 25, 202026/11/2019Cold Heart Study: A Randomized Pilot Trial of Surfactant TherapyThe Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Following Deep Hypothermic Circulatory Arrest During Cardiac SurgeryCongenital Heart Disease;Hypoplastic Left Heart SyndromeDrug: Curosurf;Drug: ShamUniversity of MichiganChiesi Farmaceutici S.p.A.RecruitingN/A12 WeeksAll60Phase 1United States
3NCT04090697
(ClinicalTrials.gov)
December 20, 20194/4/2019Use of Oxandrolone to Promote Growth in Infants With HLHSUse of Oxandrolone to Promote Growth in Infants With Hypoplastic Left Heart Syndrome: A Phase I/II Pilot StudyHypoplastic Left Heart;Congenital Heart DiseaseDrug: OxandroloneHealthCore-NERINULLRecruitingN/A14 DaysAll100Phase 1/Phase 2United States;Canada
4NCT03406884
(ClinicalTrials.gov)
October 16, 201920/12/2017The CHILD Trial: Hypoplastic Left Heart Syndrome Study.Autologous Cardiac Stem Cell Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study.Hypoplastic Left Heart SyndromeBiological: c-kit+ cellsUniversity of MiamiNULLRecruiting1 Day21 DaysAll32Phase 1United States
5NCT03779711
(ClinicalTrials.gov)
June 6, 20194/12/2018Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart SyndromePhase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Stage II Surgical Repair of Right Ventricular Dependent Variants of Hypoplastic Left Heart Syndrome (AutoCell-S2)Hypoplastic Left Heart SyndromeBiological: Autologous (self) mononuclear cells derived from umbilical cord blood;Procedure: Stage II Surgical repairTimothy J Nelson, MD, PhDUniversity of Oklahoma;Children's Hospital of Philadelphia;Children's Hospital Los Angeles;Children's Hospital Colorado;Children's Hospitals and Clinics of Minnesota;Ochsner Health System;Children's of Alabama;Children's Hospital Medical Center, CincinnatiActive, not recruitingN/A12 MonthsAll95Phase 2United States
6NCT03525418
(ClinicalTrials.gov)
February 21, 201819/2/2018Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)Lomecel-B Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase I/II Study (ELPIS)HLHSBiological: Longeveron Mesenchymal Stem CellsLongeveron Inc.NULLCompletedN/A1 YearAll10Phase 1/Phase 2United States
7NCT03136835
(ClinicalTrials.gov)
February 2, 201828/10/2015Maternal Hyperoxygenation in Congenital Heart DiseaseMaternal Hyperoxygenation in Congenital Heart DiseaseHypoplastic Left Heart SyndromeDrug: Maternal HyperoxygenationThe Hospital for Sick ChildrenNULLRecruiting18 YearsN/AFemale20Phase 1/Phase 2Canada
8NCT03079401
(ClinicalTrials.gov)
November 27, 20178/3/2017Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left VentricleMesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left VentricleHypoplastic Left Heart Syndrome;Atrioventricular CanalBiological: MPC; rexlemestrocel-LBoston Children's HospitalNULLActive, not recruitingN/A5 YearsAll19Phase 1/Phase 2United States
9NCT02781922
(ClinicalTrials.gov)
June 201619/5/2016Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group StudyHypoplastic Left Heart Syndrome;Single VentricleGenetic: Autologous cardiac stem cells (JRM-001)Metcela Inc.NULLRecruiting0 Years6 YearsAll40Phase 3Japan
10NCT03147014
(ClinicalTrials.gov)
January 1, 20164/5/2017Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart DiseaseCardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart DiseaseHypoplastic Left Heart Syndrome;Aortic Coarctation;Atrial Septal AneurysmBiological: Maternal hyperoxygenationBeijing Anzhen HospitalNULLRecruitingN/AN/AFemale600N/AChina
11NCT02080637
(ClinicalTrials.gov)
July 201521/2/2014Ambrisentan in Single VentricleSafety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric PatientsHypoplastic Left Heart Syndrome;Hypoplastic Right-sided Heart ComplexDrug: Ambrisentan;Other: PlaceboKevin HillNULLCompleted24 Months120 MonthsAll16Phase 2United States
12JPRN-UMIN000017311
2015/05/0101/05/2015Hypoxia inhalation therapy for infants with pulmonary congestion caused by congenital heart disease.Hypoxia inhalation therapy for infants with pulmonary congestion caused by congenital heart disease. - Hypoxia inhalation therapy for infants hypoplastic left heart syndrome, coarctation of aorta, interruption of aorta, truncus arteriosus, double outlet of right ventricle (Taussig-Bing anomaly), single ventriclesHypoxia inhalation
nitrogen inhalation
Institutional Review Board of Kagoshima UniversityNULLPending1days-old365days-oldMale and Female30Not selectedJapan
13NCT02398604
(ClinicalTrials.gov)
April 201524/12/2014Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart SyndromeAllogeneic Human MEsenchymal Stem Cell (hMSC) Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study.Hypoplastic Left Heart SyndromeDrug: Allo-hMSCs;Drug: PlaceboLongeveron Inc.NULLTerminatedN/A30 DaysAll5Phase 1United States
14NCT01883076
(ClinicalTrials.gov)
May 15, 201311/6/2013Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart SyndromePhase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart SyndromeHypoplastic Left Heart SyndromeBiological: autologous cell-based deliveryTimothy J Nelson, MD, PhDUniversity of Oklahoma;Children's Hospital of Philadelphia;Children's Hospitals and Clinics of Minnesota;Children's Hospital Los Angeles;Children's Hospital Colorado;Mayo ClinicCompletedN/A18 MonthsAll30Phase 1United States
15NCT01829750
(ClinicalTrials.gov)
April 20139/4/2013Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart DiseaseHypoplastic Left Heart Syndrome;Single Right Ventricle;Single Left VentricleGenetic: Cardiac progenitor cell infusionOkayama UniversityTranslational Research Informatics Center, Kobe, Hyogo, JapanCompletedN/A20 YearsAll34Phase 2Japan
16NCT01445041
(ClinicalTrials.gov)
September 1, 201115/9/2011Safety and Feasibility Study of Umbilical Cord Blood Cells for Infants With Hypoplastic Left Heart SyndromeAutologous Cord Blood Cells for Patients With HLHS: Phase I Study of Feasibility and SafetyHypoplastic Left Heart SyndromeBiological: Autologous Umbilical Cord BloodMichael CottenNULLTerminatedN/A2 DaysAll7Phase 1United States
17NCT01292551
(ClinicalTrials.gov)
February 20118/2/2011Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.Treatment With Endothelin Antagonist to Tcpc Patients; a Multicenter, Randomized, Prospective Study Measuring Maximal O2 Uptake in Ergometer Bicycle TestHypoplastic Left Heart Syndrome;Tricuspid Atresia;Other Specified Congenital Anomalies of HeartDrug: Bosentan;Drug: PlaceboRigshospitalet, DenmarkAarhus University Hospital;Bispebjerg Hospital;ActelionCompleted15 YearsN/ABoth75Phase 2Denmark;Sweden
18EUCTR2010-022389-28-DK
(EUCTR)
12/11/201026/10/2010Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test.[TEMPO-study].Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test.[TEMPO-study]. Patients with a univentricular heart, who have recieved paliating surgery in the form of TCPC operation
MedDRA version: 14.1;Level: PT;Classification code 10021076;Term: Hypoplastic left heart syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: TracleerLars SøndergaardNULLNot RecruitingFemale: yes
Male: yes
Denmark
19NCT00974025
(ClinicalTrials.gov)
June 20099/9/2009Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated PatientsVitamin C May Improve Endothelial Function and Exercise Capacity in Functional Single Ventricle Patients After Fontan PalliationFontan Procedure;Hypoplastic Left Heart Syndrome;Tricuspid AtresiaDietary Supplement: Vitamin C;Dietary Supplement: PlaceboUniversity of MichiganGriese-Hutchinson Champions for Children's Hearts Investigator AwardCompleted8 Years25 YearsAll53N/AUnited States
20EUCTR2008-007413-76-FI
(EUCTR)
27/02/200923/12/2008Metyyliprednisolonin farmakokinetiikka ja -dynamiikka lasten avosydänleikkausten yhteydessäMetyyliprednisolonin farmakokinetiikka ja -dynamiikka lasten avosydänleikkausten yhteydessä Lasten ja nuorten sairaalassa (HUS) hoidettavat 1-12 kk ikäiset avosydänleikkaukseen tulevat potilaat, joilla on sydänvikanan TOF, AVSD tai VSD.Lasten ja nuorten sairaalassa (HUS) hoidettavat korkeintaan 28 päivän ikäiset avosydänleikkaukseen tulevat potilaat, joilla on sydänvikana TGA, HLHS tai IAA.
MedDRA version: 9.1;Level: LLT;Classification code 10010495;Term: Congenital heart disease NOS
Trade Name: Solu-Medrol
INN or Proposed INN: metyyliprednisoloninatriumsuksinaatti
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Pertti SuominenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Finland
21NCT00507819
(ClinicalTrials.gov)
December 200725/7/2007Sildenafil After the Fontan OperationThe Sildenafil After Fontan Operation StudyHypoplastic Left Heart Syndrome;Tricuspid AtresiaDrug: Sildenafil;Drug: PlaceboChildren's Hospital of PhiladelphiaThe Mark H. and Blanche M. Harrington FoundationCompleted8 Years40 YearsAll28Phase 2United States
22NCT00513240
(ClinicalTrials.gov)
September 20067/8/2007Erythropoetin Neuroprotection for Neonatal Cardiac SurgeryErythropoetin Neuroprotection for Neonatal Cardiac SurgeryCongenital Heart Disease;Hypoplastic Left Heart Syndrome;Transposition of the Great Arteries;Aortic Arch Hypoplasia or InterruptionDrug: Erythropoetin;Drug: Normal salineBaylor College of MedicineThe Dana Foundation;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)CompletedN/A30 DaysAll62Phase 1/Phase 2United States