[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05918211":3,"trial-entities:NCT05918211":668,"trial-summary:NCT05918211":671},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":9,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":48,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":658,"overall_officials":663,"references":666,"see_also_links":667},"NCT05918211","MZ_Udenafil-05","Fontan Udenafil Exercise Longitudinal Assessment Trial - 2","Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)","RECRUITING","2025-10-28","2025-10","2023-10-30","Mezzion Pharma Co. Ltd","INDUSTRY",true,"This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.","This study is a 26 week, prospective, multicenter, randomized, double-blinded, placebo-controlled safety and efficacy study of udenafil vs. placebo in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption (VO2 mL\u002Fkg\u002Fmin) as measured by maximal cardiopulmonary exercise test (CPET) reading laboratory who will be blinded to treatment allocation.",[18],"Single Ventricle Heart Disease",[20,21,22,23,24],"Fontan","Maximal Oxygen Consumption","Work Rate","VO2 at VAT","Ventilatory Efficiency","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},436,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Udenafil","Active drug",[38],"Drug",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Placebo","Matching Placebo",[40],[44],{"measure":45,"description":46,"timeFrame":47},"Change in Exercise Capacity","The change in exercise capacity (as measured by maximal VO2 at maximum exercise effort) from baseline to 26 weeks (or study completion)","Baseline to 26 Weeks",[49,53,56,59],{"measure":50,"description":51,"timeFrame":52},"Change in VO2 at the ventilatory anaerobic threshold (VAT)","Change in peak oxygen consumption (VO2) from baseline to Week 26 as measured by maximal central cardiopulmonary exercise test (CPET) reading laboratory.","Baseline to 26 weeks",{"measure":54,"description":55,"timeFrame":52},"Change in Enhanced Liver Fibrosis (ELF) Score","Change from baseline to Week 26 in the Enhanced Liver Fibrosis (ELF) Score calculated by the change in the following biomarkers: hyaluronic acid, amino-terminal propeptide of type III collagen, and tissue inhibitor of metalloproteinase-1. subjects with scores of \\\u003C7.7 were assigned to the no or mild fibrosis group; 7.7 to 9.8 to the moderate fibrosis group, and \\>9.8 to the severe fibrosis group.",{"measure":57,"description":58,"timeFrame":52},"Work rate (watts) at ventilatory anaerobic threshold (VAT)","Change from baseline to 26 weeks in work rate in watts at the ventilatory anaerobic threshold as measured by the central cardiopulmonary exercise test reading laboratory.",{"measure":60,"description":61,"timeFrame":52},"Change in ventilatory efficiency (VE\u002FVCO2) at ventilatory anaerobic threshold","Change from baseline to Week 26 in ventilatory efficiency calculated by ventilatory efficiency divided by minute carbon dioxide production at the ventilatory anaerobic threshold (VE\u002FVCO2 at VAT).","ALL","12 Years","18 Years",false,{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Inclusion Criteria:\n\n1. Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment.\n2. Participant consent or parental\u002Fguardian consent and participant assent.\n3. Participant fluency in primary language of country in which study is being conducted.\n4. Current antiplatelet or anticoagulant therapy.\n\nExclusion Criteria:\n\n1. Height \\\u003C 132 cm.\n2. Weight \\\u003C 40 kg.\n3. Hospitalization for acute decompensated heart failure within the last 12 months.\n4. Current intravenous inotropic drugs.\n5. Undergoing evaluation for heart transplantation or listed for transplantation.\n6. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis.\n7. Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of \\> 4 mmHg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography, obtained prior to screening for the trial.\n8. Single lung physiology with greater than 80% flow to one lung.\n9. Failure to achieve maximal exertion (defined as RER \\\u003C 1.10) on screening\u002Fbaseline exercise test.\n10. Peak minute oxygen consumption (VO2) less than 45% or ≥ 80% of predicated for age and gender at enrollment.\n11. Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within 6 months prior to enrollment.\n12. Severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.\n13. History of significant renal (serum creatinine \\> 2.0), hepatic (serum AST and\u002For ALT \\> 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications.\n14. Inability to complete exercise testing at baseline screening.\n15. Subjects with a pacemaker whose heart rate at peak exercise is controlled by the extrinsic pacemaker as opposed to a native atrial rhythm.\n16. History of PDE-5 inhibitor use within 12 months prior to enrollment. (Treatment is defined as chronic therapy as opposed to a single dose.)\n17. History of any other medication for treatment of pulmonary hypertension within 3 months before study onset.\n18. Known intolerance to oral udenafil.\n19. Frequent use of medications or other substances that inhibit or induce CYP3A4.\n20. Current use of alpha-blockers or nitrates.\n21. Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results.\n22. Noncardiac medical, psychiatric, and\u002For social disorder that would prevent successful completion of planned study testing or would invalidate its results.\n23. Cardiac care, ongoing or planned, at a non-study center that would impede study completion.\n24. For females: Pregnancy at the time of screening, pregnancy planned before study completion, or refusal to use an acceptable method of contraception for study duration if sexually active.\n25. Unable to abstain or limit intake of grapefruit juice and grapefruit containing drinks during the duration of the trial.\n26. Refusal to provide written informed consent\u002Fassent.\n27. In the opinion of the investigator, the subject is likely to be non-compliant with the study protocol.\n28. History of clinically significant thromboembolic event, in the option of the site Principal Investigator, that may put the subject at increased risk of a subsequent event while participating in the study.\n29. Coronavirus disease 2019 (COVID-19) vaccination or symptoms of COVID-19 infection within 7 days of Visit 1.\n30. Not taking antiplatelet or anticoagulant therapy.",[71,72],"CHILD","ADULT",[74,92,107,122,136,150,165,180,195,210,225,239,253,268,282,297,308,323,338,353,367,382,397,408,423,439,454,468,482,497,511,526,541,556,570,585,600,615,635,648],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"Phoenix Children's Hospital","Phoenix","Arizona","85016","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Jade Porche","CONTACT","602-933-6835","jporche@phoenixchildrens.com",{"name":87,"role":88},"Arash Sabati, MD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},33.44838,-112.07404,{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":79,"contacts":97,"geoPoint":104},"Arkansas Children's","Little Rock","Arkansas","72202",[98,102],{"name":99,"role":83,"phone":100,"email":101},"Wendy Haley","501-364-2237","haleyw@archildren's.org",{"name":103,"role":88},"Dala Zakaria, MD",{"lat":105,"lon":106},34.74648,-92.28959,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":79,"contacts":112,"geoPoint":119},"Children's Hospital of Los Angeles","Los Angeles","California","90027",[113,117],{"name":114,"role":83,"phone":115,"email":116},"Matthew Dam","323-361-7881","mdam@chla.usc.edu",{"name":118,"role":88},"Jon Detterich, MD",{"lat":120,"lon":121},34.05223,-118.24368,{"facility":123,"status":8,"city":124,"state":110,"zip":125,"country":79,"contacts":126,"geoPoint":133},"Rady Children's Hospital","San Diego","92123",[127,131],{"name":128,"role":83,"phone":129,"email":130},"Mark Abcede","619-987-0650","mabcede1@rchsd.org",{"name":132,"role":88},"Jessica Haley, MD",{"lat":134,"lon":135},32.71571,-117.16472,{"facility":137,"status":8,"city":138,"state":110,"zip":139,"country":79,"contacts":140,"geoPoint":147},"UCSF Benioff Children's Hospital","San Francisco","94158",[141,145],{"name":142,"role":83,"phone":143,"email":144},"Aisling Conneally","510-600-2965","aisling.conneally@ucsf.edu",{"name":146,"role":88},"Doaa Aly, MD",{"lat":148,"lon":149},37.77493,-122.41942,{"facility":151,"status":8,"city":152,"state":153,"zip":154,"country":79,"contacts":155,"geoPoint":162},"Children's Hospital of Colorado","Denver","Colorado","80045",[156,160],{"name":157,"role":83,"phone":158,"email":159},"Andrea DeMarsh","216-906-7931","andrea.demarsh@childrenscolorado.org",{"name":161,"role":88},"Roni Jacobsen",{"lat":163,"lon":164},39.73915,-104.9847,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":79,"contacts":170,"geoPoint":177},"Yale School of Medicine","New Haven","Connecticut","06510",[171,175],{"name":172,"role":83,"phone":173,"email":174},"Amanda Catucci","631-897-6722","amanda.catucci@yale.edu",{"name":176,"role":88},"Meredith Leslie, MD",{"lat":178,"lon":179},41.30815,-72.92816,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":79,"contacts":185,"geoPoint":192},"Nemours Children's Hospital","Wilmington","Delaware","19803",[186,190],{"name":187,"role":83,"phone":188,"email":189},"Carol Prospero","302-651-6686","carol.prospero@nemours.org",{"name":191,"role":88},"Mark Cartoski, MD",{"lat":193,"lon":194},39.74595,-75.54659,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":79,"contacts":200,"geoPoint":207},"Childrens National Medical Center","Washington D.C.","District of Columbia","20010",[201,205],{"name":202,"role":83,"phone":203,"email":204},"Stacy Davenport","240-547-9804","amatthews@childrensnational.org",{"name":206,"role":88},"Sairah Khan, MD",{"lat":208,"lon":209},38.89511,-77.03637,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":79,"contacts":215,"geoPoint":222},"UF Health Shands Hospital","Gainesville","Florida","32608",[216,220],{"name":217,"role":83,"phone":218,"email":219},"Dalia Lopez-Colon","352-281-6723","dalylc@ufl.edu",{"name":221,"role":88},"Dipankar Gupta, MD",{"lat":223,"lon":224},29.65163,-82.32483,{"facility":226,"status":8,"city":227,"state":213,"zip":228,"country":79,"contacts":229,"geoPoint":236},"Joe DiMaggio Children's Hospital","Hollywood","33021",[230,234],{"name":231,"role":83,"phone":232,"email":233},"Norma Barton","954-265-4466","NBarton@mhs.net",{"name":235,"role":88},"Melissa Diamond, MD",{"lat":237,"lon":238},26.0112,-80.14949,{"facility":240,"status":8,"city":241,"state":213,"zip":242,"country":79,"contacts":243,"geoPoint":250},"Johns Hopkins All Children's Hospital","St. Petersburg","33701",[244,248],{"name":245,"role":83,"phone":246,"email":247},"Lexie Dallas","727-767-2465","adallas@jhmi.edu",{"name":249,"role":88},"Jamie Decker, MD",{"lat":251,"lon":252},27.77086,-82.67927,{"facility":254,"status":8,"city":255,"state":256,"zip":257,"country":79,"contacts":258,"geoPoint":265},"Children's Healthcare of Atlanta","Atlanta","Georgia","30329",[259,263],{"name":260,"role":83,"phone":261,"email":262},"Jessica Braun","404-785-3828","jessica.braun@choa.org",{"name":264,"role":88},"Michael Lopez, MD",{"lat":266,"lon":267},33.749,-84.38798,{"facility":269,"status":8,"city":270,"state":256,"zip":271,"country":79,"contacts":272,"geoPoint":279},"Children's Hospital of Georgia","Augusta","30912",[273,277],{"name":274,"role":83,"phone":275,"email":276},"Michelle Collins","706-721-9680","MCOLLINS2@augusta.edu",{"name":278,"role":88},"Mark Vranicar, MD",{"lat":280,"lon":281},33.47097,-81.97484,{"facility":283,"status":8,"city":284,"state":285,"zip":286,"country":79,"contacts":287,"geoPoint":294},"Lurie Children's Hospital","Chicago","Illinois","60611",[288,292],{"name":289,"role":83,"phone":290,"email":291},"Jessica Bhavsar","312-227-4432","jbhavsar@luriechildrens.org",{"name":293,"role":88},"Kendra Ward, MD",{"lat":295,"lon":296},41.85003,-87.65005,{"facility":298,"status":8,"city":284,"state":285,"zip":299,"country":79,"contacts":300,"geoPoint":307},"University of Chicago","60637",[301,305],{"name":302,"role":83,"phone":303,"email":304},"Becky Puplava","773-702-2879","rpuplava@bsd.uchicago.edu",{"name":306,"role":88},"Michael Earing, MD",{"lat":295,"lon":296},{"facility":309,"status":8,"city":310,"state":311,"zip":312,"country":79,"contacts":313,"geoPoint":320},"Boston Children's Hospital","Boston","Massachusetts","02115",[314,318],{"name":315,"role":83,"phone":316,"email":317},"Tom Giorgio","617-355-4201","thomas.giorgio@cardio.chboston.org",{"name":319,"role":88},"Rahul Rathod, MD",{"lat":321,"lon":322},42.35843,-71.05977,{"facility":324,"status":8,"city":325,"state":326,"zip":327,"country":79,"contacts":328,"geoPoint":335},"University of Michigan","Ann Arbor","Michigan","48109",[329,333],{"name":330,"role":83,"phone":331,"email":332},"Cynthia Smith","734-615-0590","csmithw@med.umich.edu",{"name":334,"role":88},"Kurt Schumacher, MD",{"lat":336,"lon":337},42.27756,-83.74088,{"facility":339,"status":8,"city":340,"state":341,"zip":342,"country":79,"contacts":343,"geoPoint":350},"Children's Mercy Hospital Kansas City","Kansas City","Missouri","64108",[344,348],{"name":345,"role":83,"phone":346,"email":347},"Dara Watkins","816-302-3633","djwatkins@cmh.org",{"name":349,"role":88},"Jonathan B Wagner, MD",{"lat":351,"lon":352},39.09973,-94.57857,{"facility":354,"status":8,"city":355,"state":341,"zip":356,"country":79,"contacts":357,"geoPoint":364},"Washington University","St Louis","63130",[358,362],{"name":359,"role":83,"phone":360,"email":361},"Mason Basler","618-579-5674","basler@wustl.edu",{"name":363,"role":88},"William Orr, MD",{"lat":365,"lon":366},38.62727,-90.19789,{"facility":368,"status":8,"city":369,"state":370,"zip":371,"country":79,"contacts":372,"geoPoint":379},"University of Nebraska Children's Hospital and Medical Center","Omaha","Nebraska","68114",[373,377],{"name":374,"role":83,"phone":375,"email":376},"Morgan Loeffelbein","402-559-0681","mloeffelbein@unmc.edu",{"name":378,"role":88},"Angela Yetman, MD",{"lat":380,"lon":381},41.25626,-95.94043,{"facility":383,"status":384,"city":385,"state":385,"zip":386,"country":79,"contacts":387,"geoPoint":394},"Mt. Sinai Children's Hospital","NOT_YET_RECRUITING","New York","10029",[388,392],{"name":389,"role":83,"phone":390,"email":391},"Xueru Mu","347-335-7148","xueru.mu@mssm.edu",{"name":393,"role":88},"Neha Bansel, MD",{"lat":395,"lon":396},40.71427,-74.00597,{"facility":398,"status":8,"city":385,"state":385,"zip":399,"country":79,"contacts":400,"geoPoint":407},"New York-Presbyterian Children's Hospital","10032",[401,405],{"name":402,"role":83,"phone":403,"email":404},"Katrina Golub","212-342-1562","kg2697@cumc.columbia.edu",{"name":406,"role":88},"Christopher Petit, MD",{"lat":395,"lon":396},{"facility":409,"status":384,"city":410,"state":411,"zip":412,"country":79,"contacts":413,"geoPoint":420},"Dana.Amaro@atriumhealth.org","Charlotte","North Carolina","28204",[414,418],{"name":415,"role":83,"phone":416,"email":417},"Dana Amaro","704-355-4692","dana.amaro@atriumhealth.org",{"name":419,"role":88},"Matthew Schwartz, MD",{"lat":421,"lon":422},35.22709,-80.84313,{"facility":424,"status":8,"city":425,"state":411,"zip":426,"country":79,"contacts":427,"geoPoint":436},"Duke University Medical Center","Durham","27710",[428,431,434],{"name":429,"role":83,"email":430},"Alexi Pifer","alexis.pifer@duke.edu",{"name":432,"role":83,"email":433},"Melissa Harward","melissa.harward@duke.edu",{"name":435,"role":88},"Gregory Fleming, MD",{"lat":437,"lon":438},35.99403,-78.89862,{"facility":440,"status":8,"city":441,"state":442,"zip":443,"country":79,"contacts":444,"geoPoint":451},"Cincinnati Childrens Hospital Medical Center","Cincinnati","Ohio","45206",[445,449],{"name":446,"role":83,"phone":447,"email":448},"Mariah Palmer","513-636-9516","Mariah.Palmer@cchmc.org",{"name":450,"role":88},"Sasha Opotowsky, MD",{"lat":452,"lon":453},39.12711,-84.51439,{"facility":455,"status":8,"city":456,"state":442,"zip":457,"country":79,"contacts":458,"geoPoint":465},"Cleveland Clinic","Cleveland","44195",[459,463],{"name":460,"role":83,"phone":461,"email":462},"Ewing Paige","216-445-8798","ewingp@ccf.org",{"name":464,"role":88},"Shahnawaz Amdani, MD",{"lat":466,"lon":467},41.4995,-81.69541,{"facility":469,"status":8,"city":470,"state":442,"zip":471,"country":79,"contacts":472,"geoPoint":479},"Nationwide Children's Hospital","Columbus","43215",[473,477],{"name":474,"role":83,"phone":475,"email":476},"Victoria Shay","614-355-5819","victoria.shay@nationwidechildrens.org",{"name":478,"role":88},"Omar Khalid, MD",{"lat":480,"lon":481},39.96118,-82.99879,{"facility":483,"status":8,"city":484,"state":485,"zip":486,"country":79,"contacts":487,"geoPoint":494},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[488,492],{"name":489,"role":83,"phone":490,"email":491},"Faith Alunni","570-430-5058","alunnif@chop.edu",{"name":493,"role":88},"Jon Edelson, MD",{"lat":495,"lon":496},39.95238,-75.16362,{"facility":498,"status":8,"city":499,"state":485,"zip":500,"country":79,"contacts":501,"geoPoint":508},"Children's Hospital of Pittsburgh","Pittsburgh","15224",[502,506],{"name":503,"role":83,"phone":504,"email":505},"Niklas Gerhart","412-692-6742","gerhartne4@upmc.edu",{"name":507,"role":88},"Lauren Carlozzi, MD",{"lat":509,"lon":510},40.44062,-79.99589,{"facility":512,"status":8,"city":513,"state":514,"zip":515,"country":79,"contacts":516,"geoPoint":523},"MUSC Pediatric Research Group","Charleston","South Carolina","29425",[517,521],{"name":518,"role":83,"phone":519,"email":520},"Susannah C Wakefield","843-792-8317","wakefies@musc.edu",{"name":522,"role":88},"Andrew Atz, MD",{"lat":524,"lon":525},32.77632,-79.93275,{"facility":527,"status":8,"city":528,"state":529,"zip":530,"country":79,"contacts":531,"geoPoint":538},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",[532,536],{"name":533,"role":83,"phone":534,"email":535},"Sherry Bowman","615-936-0061","sherry.bowman@vumc.org",{"name":537,"role":88},"Benjamin Frischhertz, MD",{"lat":539,"lon":540},36.16589,-86.78444,{"facility":542,"status":8,"city":543,"state":544,"zip":545,"country":79,"contacts":546,"geoPoint":553},"UT Southwestern Medical Center","Dallas","Texas","75235",[547,551],{"name":548,"role":83,"phone":549,"email":550},"Aruna Ayalasomayajula","702-340-7830","aruna.ayalasomayajula@utsouthwestern.edu",{"name":552,"role":88},"Matt Lemler, MD",{"lat":554,"lon":555},32.78306,-96.80667,{"facility":557,"status":8,"city":558,"state":544,"zip":559,"country":79,"contacts":560,"geoPoint":567},"Texas Children's Hospital","Houston","77030",[561,565],{"name":562,"role":83,"phone":563,"email":564},"Sara Stephens","832-826-5613","sara.stephens@bcm.edu",{"name":566,"role":88},"Daniel Penny, MD",{"lat":568,"lon":569},29.76328,-95.36327,{"facility":571,"status":8,"city":572,"state":573,"zip":574,"country":79,"contacts":575,"geoPoint":582},"Primary Children's Medical Center","Salt Lake City","Utah","84113",[576,580],{"name":577,"role":83,"phone":578,"email":579},"Andrea Dunn","801-213-7609","andrea.dunn@hsc.utah.edu",{"name":581,"role":88},"Richard Williams, MD",{"lat":583,"lon":584},40.76078,-111.89105,{"facility":586,"status":8,"city":587,"state":588,"zip":589,"country":79,"contacts":590,"geoPoint":597},"Seattle Children's Hospital","Seattle","Washington","98105",[591,595],{"name":592,"role":83,"phone":593,"email":594},"Ranjini Prakash","206-987-2000","Ranjini.Prakash@seattlechildrens.org",{"name":596,"role":88},"Matthew Files, MD",{"lat":598,"lon":599},47.60621,-122.33207,{"facility":601,"status":8,"city":602,"state":603,"zip":604,"country":79,"contacts":605,"geoPoint":612},"Children's Hospital of Wisconsin","Milwaukee","Wisconsin","53226",[606,610],{"name":607,"role":83,"phone":608,"email":609},"Jennifer Yauck","414-266-2325","jyauck@childrenswi.org",{"name":611,"role":88},"Stephanie Handler, MD",{"lat":613,"lon":614},43.0389,-87.90647,{"facility":616,"status":8,"city":617,"state":618,"zip":619,"country":620,"contacts":621,"geoPoint":632},"Sejong General Hospital","Bucheon-si","Gyeonggi-do","14754","South Korea",[622,626,630],{"name":623,"role":83,"phone":624,"email":625},"Jiyeun Jeong","010-9221-5114","seize86@naver.com",{"name":627,"role":83,"phone":628,"email":629},"Yubin Min","032-340-1782","yubin0812@naver.com",{"name":631,"role":88},"Seongho Kim, MD",{"lat":633,"lon":634},37.49889,126.78306,{"facility":636,"status":8,"city":637,"zip":638,"country":620,"contacts":639,"geoPoint":645},"Seoul National University Children's Hospital","Seoul","03080",[640,643],{"name":641,"role":83,"email":642},"Gowoon Choi","go9979@snu.ac.kr",{"name":644,"role":88},"Gibeom Kim, MD",{"lat":646,"lon":647},37.566,126.9784,{"facility":649,"status":8,"city":637,"zip":650,"country":620,"contacts":651,"geoPoint":657},"Yonsei Severance Hospital","03722",[652,655],{"name":653,"role":83,"email":654},"Juwon Heo","jwheo92@yuhs.ac",{"name":656,"role":88},"Saeyong Jung, MD",{"lat":646,"lon":647},[659],{"name":660,"role":83,"phone":661,"email":662},"WG Kim","443.699.6746","wgkim@mezzion.com",[664],{"name":660,"affiliation":12,"role":665},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":669,"biomarkers":670},[18],[],{"nct_id":4,"found":14,"summary":672,"prompt_version":682},{"design":673,"status":674,"heading":675,"summary":676,"follow_up":677,"word_count":678,"commitments":679,"compensation":680,"drugs_mentioned":681},"This is a 26-week, multicenter, randomized, double-blinded, placebo-controlled study, meaning participants will be randomly assigned to receive either udenafil or placebo, and neither you nor your doctors will know which you are receiving. The study plans to enroll 436 participants.","completed","Udenafil for Adolescents with Single Ventricle Heart Disease","This study, called the Fontan Udenafil Exercise Longitudinal Assessment Trial - 2, is looking at how well a drug called udenafil works compared to a placebo (an inactive substance that looks like the drug) in adolescents who have had a Fontan procedure for single ventricle heart disease. Researchers want to see if udenafil can improve your exercise ability. You might be able to join if you are between 12 and 18 years old, have Fontan physiology, and meet certain height and weight requirements. The study will measure changes in your exercise capacity over 26 weeks. The current recruitment status is unclear, but the study plans to enroll 436 participants.","Your exercise capacity will be measured at 26 weeks after starting the study.",109,"You would participate in the study for 26 weeks, during which your exercise capacity will be measured at the beginning and at the end of this period.","Not stated in the trial record.",[35,40],"v2"]