[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100188549":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":27,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":10,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Healthy Volunteers",null,"Enroll up to 120 healthy volunteers, in order to obtain approximately 55 evaluable healthy volunteers matched to pulmonary arterial hypertension subjects for age and sex",{"label":13,"type":10,"description":14,"interventionNames":10},"Pulmonary Arterial Hypertension Subjects","150 subjects with pulmonary arterial hypertension; male or female, age grater than or equal to 18 - 99 years",[16],{"name":17,"affiliation":5,"role":18},"Michael A Solomon, M.D.","PRINCIPAL_INVESTIGATOR",[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Grace M Graninger, R.N.","CONTACT","(301) 496-9320","ggraninger@cc.nih.gov",{"name":17,"role":22,"phone":23,"phoneExt":10,"email":26},"msolomon@cc.nih.gov",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-77.10026,38.98067,{"lat":40,"lon":39},[43],{"name":44,"role":22,"phone":45,"phoneExt":46,"email":47},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100188549","natural-history-study-of-biomarkers-in-pulmonary-arterial-hypertension-100188549",false,"NCT01730092","Natural History Study of Biomarkers in Pulmonary Arterial Hypertension","A Natural History Study of Novel Biomarkers in Pulmonary Arterial Hypertension","* ELIGIBILITY:\n\nThe study will enroll subjects with confirmed and suspected NYHA\u002FWHO Group 1 PH (68) as well as age and sex matched control subjects. Subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. There is no exclusion based on race or sex.\n\nINCLUSION AND EXCLUSION CRITERIA FOR PAH SUBJECTS:\n\nInclusion Criteria:\n\nThe following parameters on RHC are required to meet the hemodynamic definition of PAH (NYHA\u002FWHO Group I PH):\n\n* mean pulmonary artery pressure of \\> 25 mmHg at rest,\n* pulmonary capillary wedge pressure of \\\u003C 15 mmHg (or a left ventricular end-diastolic pressure of \\\u003C 12 mmHg), and\n* pulmonary vascular resistance of \\> 3 Wood units (240 dyn s cm-5).\n\nFor patients with suspected PAH (Group I PH) who have not undergone a RHC and\u002For additional testing to confirm the diagnosis, this testing will be completed as clinically indicated under a procedural consent. If clinically indicated (diagnostic) testing indicates that the subject with suspected PAH does not in fact meet standard criteria for PAH (Group I PH), then the subject will be removed from the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)\n* Age less than 18 years\n* Inability to provide informed written consent for participation in the study\n\nINCLUSION AND EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS:\n\nInclusion Criteria for Control Subjects\n\nAny healthy man or woman who is the appropriate age and sex for matching to a PAH patient\n\n* Must be eligible for MRI and Gadolinium Based MRI studies\n* Must be eligible for CT and Iodine Based Contrast CT studies\n\nExclusion Criteria for Healthy Control Subjects\n\n* Current pregnancy or breastfeeding (All women of childbearing potential will be required to have a screening urine or blood pregnancy test)\n* Electrocardiographic evidence of clinically relevant heart disease\n* Symptoms of coronary or cardiac insufficiency\n* More than one major risk factor for coronary artery disease (excluding age and sex)\n* Obesity (defined as a body mass index \\> 30 kg\u002Fm\\^2)\n* History of underlying conditions\u002Frisk factors associated with pulmonary hypertension such as collagen vascular disease, HIV infection, use of appetite suppressants, chronic liver disease or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, hypoxemia and\u002For significant pulmonary parenchymal disease\n* Systemic hypertension that is not well controlled (i.e. blood pressure at the time of screening \\>140\u002F90 mmHg in adults \\\u003C 60 years old or \\>150\u002F90 mmHg in adults 60 years or older) on medications. Subjects taking \\> 2 anti-hypertensive medications will be excluded irrespective of their current blood pressure at time of screening\n* Anemia, thrombocytopenia or coagulopathy\n* Renal insufficiency (defined as an estimated glomerular filtration rate of \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 of body surface area)\n* Active tobacco use (\\> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation or any tobacco use prior to completion of the study\n* Inability to provide informed written consent for participation in the study\n* History of recreational drug use with the exception of marijuana (as long as marijuana use was \\> 3 months from the time of study screening).\n\n  * Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.\n\nExclusion Criteria for MRI in Healthy Control Subjects and Subjects with PAH\n\nThese contraindications include but are not limited to the following devices or conditions:\n\n1. Implanted cardiac pacemaker or defibrillator\n2. Cochlear Implants\n3. Ocular foreign body (e.g. metal shavings)\n4. Embedded shrapnel fragments\n5. Central nervous system aneurysm clips\n6. Implanted neural stimulator\n7. Any implanted device that is incompatible with MRI\n8. Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and severe dyspnea at rest\n9. Subjects requiring monitored sedation for MRI studies\n10. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)\n11. Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.\n\nExclusion Criteria for Gadolinium Based MRI Studies Only:\n\n1. History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone\n2. Chronic kidney disease (an estimated glomerular filtration rate of \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 of body surface area)\n\nExclusion Criteria for Cardiac Computed Tomography in Healthy Control Subjects and Subjects with PAH:\n\n1\\) Subjects with a condition precluding entry into the scanner (e.g. morbid\n\nobesity, claustrophobia, etc.)\n\nExclusion Criteria for Iodine Based Contrast CTA Studies Only:\n\n1. Serum creatinine \\> 1.4 mg\u002FdL\n2. History of multiple myeloma\n3. Use of metformin-containing products less than 24 hours prior to contrast administration\n4. History of significant allergic reaction to CTA contrast agents despite pre-medication with diphenhydramine and prednisone",true,"ALL","18 Years","100 Years",{"count":62,"type":63},270,"ESTIMATED","OBSERVATIONAL","Background:\n\n\\- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause. Researchers want to follow the natural history of all PAH patients to understand how PAH progresses in order to discover targets for future research into new treatments. To further identify treatment targets, they will compare healthy volunteers to patients with PAH.\n\nObjectives:\n\n\\- To study the natural history of PAH.\n\nEligibility:\n\n* Individuals at least 18 years of age who have PAH.\n* Healthy volunteers at least 18 years of age.\n\nDesign:\n\n* Participants with PAH will have periodic visits to the National Institutes of Health Clinical Center. After the first visit, they will return in 6 months and then yearly or every other year for as long as the study continues.\n* The first visit will take up to 3 days. It will involve the following tests:\n* Physical exam and medical history\n* Blood and urine samples\n* Heart and lung function tests and imaging studies\n* Six-minute walk test\n* Questions about exercise and physical activity\n* Healthy volunteers will have only one visit to the Clinical Center, during which they will undergo screening tests, and complete many of the same tests as patients with PAH",[67,68],"Pulmonary Disease","Pulmonary Hypertension",[70,71,72,73,74,75],"Vascular Inflammation","Microarray","Right Ventricular Function","Endothelial Dysfunction","Magnetic Resonance Imaging","Natural History","2026-06-13",{"date":78,"type":79},"2026-06-16","ACTUAL",{"date":81,"type":79},"2013-07-15",{"name":5,"class":6},1]