Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-30 @ 2:53 PM
Study NCT ID:
NCT06672861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)
Sponsor:
Kansas City Heart Rhythm Research Foundation
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
A 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/untreated 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.
A 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/untreated 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: