[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03269630":3,"trial-entities:NCT03269630":85,"trial-summary:NCT03269630":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":24,"primary_purpose":16,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":16,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":59,"locations":62,"central_contacts":78,"overall_officials":82,"references":83,"see_also_links":84},"NCT03269630","LSU","New Orleans Pulmonary Hypertension Biobank","RECRUITING","2027-10","2021-09","2021-09-10","2017-12-29","Louisiana State University Health Sciences Center in New Orleans","OTHER",false,"Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure \\>=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. The investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. Specimens will be stored for future investigations.",null,[18,19,20,21,22],"Pulmonary Hypertension","Systemic Sclerosis","Mixed Connective Tissue Disease","Heart Failure With Normal Ejection Fraction","Healthy",[],"OBSERVATIONAL",[],{"count":27,"type":28},450,"ESTIMATED",[30],{"type":13,"name":31,"description":32,"armGroupLabels":33},"No intervention. Biospecimen collection only","Biospecimen collection",[34,35,36],"Clinic patients (Comprehensive Pulmonary Hypertension Center)","Healthy controls","Outpatient right heart catheterization patients",[38],{"measure":39,"description":40,"timeFrame":41},"Collection of biospecimens","Biospecimen collection only","10 years",[],"ALL","18 Years",true,{"inclusion":47,"exclusion":52,"raw_text":58},[48,49,50,51],"Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR","Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR","Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR","Undergoing outpatient right heart catheterization",[53,54,55,56,57],"Age\\\u003C18","Pregnant","Unable to understand English","Currently incarcerated","Unwilling or unable to sign informed consent","Inclusion Criteria:\n\n* Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR\n* Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR\n* Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR\n* Undergoing outpatient right heart catheterization\n\nExclusion Criteria:\n\n* Age\\\u003C18\n* Pregnant\n* Unable to understand English\n* Currently incarcerated\n* Unwilling or unable to sign informed consent",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":75},"University Medical Center-New Orleans","New Orleans","Louisiana","70112","United States",[70],{"name":71,"role":72,"phone":73,"email":74},"Matthew Lammi, MD, MSCR","CONTACT","504-568-4634","mlammi@lsuhsc.edu",{"lat":76,"lon":77},29.95465,-90.07507,[79],{"name":80,"role":72,"phone":81,"email":74},"Matthew R Lammi, MD, MSCR","5045684634",[],[],[],{"nct_id":4,"conditions":86,"biomarkers":89},[22,87,20,18,88],"Heart failure with normal ejection fraction","Systemic Scleroderma",[],{"nct_id":4,"found":45,"summary":91,"prompt_version":100},{"design":92,"status":93,"heading":6,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an observational study, meaning no intervention is given. It plans to enroll 450 participants.","completed","This study is creating a biobank to collect samples (blood, urine, and stool) from people with pulmonary hypertension (high blood pressure in the lungs), those at high risk for it, healthy individuals, and patients undergoing a right heart catheterization (a procedure to measure heart and lung pressures). The goal is to better understand pulmonary hypertension and find new ways to guide treatment. There are no interventions or treatments being tested; this is purely for collecting samples for future research. You may be able to join if you are 18 or older and have a diagnosis of pulmonary hypertension, systemic sclerosis, or mixed connective tissue disease, or are undergoing a right heart catheterization. The study aims to collect samples for 10 years.","The primary endpoint is the collection of biospecimens, measured at 10 years.",121,"You would provide biospecimens (blood, urine, stool). The duration of your participation is not specified beyond the 10-year collection period.","Not stated in the trial record.",[],"v2"]