Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT06672861
Status
Not Yet Recruiting

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Conditions

  • Cardiac Dysautonomia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Nov 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia Patients
    Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia (Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), and Vasovagal syncope (VVS)) Patients
  • Other: Previously diagnosed/treated/undergone sinus node modification for Cardiac Dysautonomia Patients
    Previously diagnosed/treated/previously undergone sinus node modification for Cardiac Dysautonomia Patients (Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), and Vasovagal syncope (VVS)) Patients

Primary Outcome Measure

To develop and validate KCDysQ as a quality of life and symptom severity assessment tool [ Time Frame: 3 Months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Kansas City Heart Rhythm InstituteOverland ParkKansas66211-
Midwest Heart and Vascular SpecialistsOverland ParkKansas66211-
Overland Park Regional Medical CenterOverland ParkKansas66215-

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