[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567797":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":19,"studyPopulation":13,"armGroups":20,"interventions":30,"overallOfficials":35,"centralContacts":40,"locations":46,"responsibleParty":70,"collaborators":72,"id":77,"slug":13,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":13,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":13,"enrollmentInfo":85,"targetDuration":13,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":13,"overallStatus":94,"whyStopped":13,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Kansas City Heart Rhythm Research Foundation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"To develop and validate KCDysQ as a quality of life and symptom severity assessment tool","The primary objective of this study will be to develop and validate KCDysQ as a quality of life and symptom severity assessment tool that can be widely applied to patients with symptoms of cardiac dysautonomia, and doing so by proving the questionnaire's reliability, validity, responsiveness, and acceptability.","3 Months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":6,"observationalModel":13,"timePerspective":13,"maskingInfo":17},"NON_RANDOMIZED","PARALLEL",{"masking":18,"maskingDescription":13,"whoMasked":13},"NONE","With the advent of other disease specific questionnaires in patients with cardiac disease such as the AFEQT questionnaire, patients with cardiac dysautonomia have a unique symptom set that can range from mild symptoms to debilitating on a daily scale. Given that they are an underdiagnosed population who often have considerable rates of misdiagnosis, diagnostic delay, and concurrent life limiting factors not addressed by previous QOL assessments, the next logical step therefore is the development and further validation of a QOL questionnaire that serves to respect and represent the 6 domains of QOL as stated by the WHO, with representation of all four health related QOL (HRQoL), as well as focus on underrepresented areas of patients with cardiac dysautonomia.\n\nA novel disease specific KCDysQ questionnaire with questions being gathered from an extensive literature review of QOL measures in this subset of patients as well as interviews and personal interactions with these patients is proposed. It will begin with a 100-item questionnaire and proceed to use a power analysis to further stratify this. For validation of this questionnaire, it is proposed to prospectively recruit all patients with a diagnosis of POTS, IST, or VVS in a single center, and stratify them into patients with a new diagnosis\u002Funtreated POTS, IST, or VVS compared with patients who have had symptoms improvement with medication or stable disease who present for routine follow ups. Though an emerging technique and therefore a small but important percentage of this population, patients who have underwent sinus node manipulation for treatment of their IST or POTS as well will also be included, as these subsets of patients have undergone little prior evaluation.",[21,26],{"label":22,"type":6,"description":23,"interventionNames":24},"Newly diagnosed\u002Funtreated\u002Fincompletely treated for Cardiac Dysautonomia Patients","Newly diagnosed\u002Funtreated\u002Fincompletely treated for Cardiac Dysautonomia (Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), and Vasovagal syncope (VVS)) Patients",[25],"Other: Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)",{"label":27,"type":6,"description":28,"interventionNames":29},"Previously diagnosed\u002Ftreated\u002Fundergone sinus node modification for Cardiac Dysautonomia Patients","Previously diagnosed\u002Ftreated\u002Fpreviously undergone sinus node modification for Cardiac Dysautonomia Patients (Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), and Vasovagal syncope (VVS)) Patients",[25],[31],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":13},"Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)","To compare in patients with cardiac dysautonomia, newly developed disease specific questionnaire to established generalized SF-36 and EQ-5d questionnaires, as there are no disease specific questionnaires for comparison. These novel and established questionnaires will then be compared among groups who have relatively stable disease or stable symptoms with patients who will be expected to have a change in symptoms and QoL.",[22,27],[36],{"name":37,"affiliation":38,"role":39},"Dhanunjaya Lakkireddy","Kansas City Heart Rhythm Institute","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":13,"email":45},"Donita Atkins","CONTACT","816-651-1969","datkins@kchrf.com",[47,59,64],{"facility":38,"status":13,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":13},"Overland Park","Kansas","66211","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-94.67079,38.98223,{"lat":57,"lon":56},{"facility":60,"status":13,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":61,"geoPoint":63,"contacts":13},"Midwest Heart and Vascular Specialists",{"type":54,"coordinates":62},[56,57],{"lat":57,"lon":56},{"facility":65,"status":13,"city":48,"state":49,"zip":66,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":69,"contacts":13},"Overland Park Regional Medical Center","66215",{"type":54,"coordinates":68},[56,57],{"lat":57,"lon":56},{"type":71,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[73,74],{"name":38,"class":6},{"name":75,"class":76},"Midwest Heart and Vascular Specialists, Overland Park, KS","UNKNOWN","100567797",false,"NCT06672861","Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)","Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) in Patients With Postural Orthostatic Tachycardia Syndrome, Inappropriate Sinus Tachycardia, and Other Disorders of Cardiac Dysautonomia","Inclusion criteria:\n\nPatients with a Diagnosis of POTS, IST, or vasovagal syncope\n\nExclusion criteria:\n\nPatients with comorbid chronic conditions causing significant impairments in quality of life, defined as:\n\n* NYHA Class III or IV Heart Failure\n* COPD GOLD 3 or 4, Group C or D\n* Any patients with current malignancy not in remission\n* Any patient with history of Autoimmune disease requiring chronic steroid therapy or immunomodulatory agents: Rheumatoid Arthritis, Lupus, Sarcoidosis, Psoriasis All patients with ESRD requiring hemodialysis All patients with cirrhosis of any origin Any patients with solid organ or bone marrow transplant requiring immunosuppressive therapy","ALL","18 Years",{"count":86,"type":87},100,"ESTIMATED","INTERVENTIONAL",[90],"NA","Main aim will be to compare in patients with cardiac dysautonomia, newly developed disease specific questionnaire to established generalized SF-36 and EQ-5d questionnaires, as there are no disease specific questionnaires for comparison. These novel and established questionnaires will then be compared among groups who have relatively stable disease or stable symptoms with patients who will be expected to have a change in symptoms and QoL.",[93],"Cardiac Dysautonomia","NOT_YET_RECRUITING","2025-08-27",{"date":97,"type":98},"2025-08-28","ACTUAL",{"date":100,"type":87},"2026-01",{"date":102,"type":87},"2026-08",{"name":5,"class":6},3]