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

Kansas City Heart Rhythm Research Foundation

Status: Not yet enrolling

Conditions: Cardiac Dysautonomia

Treatments: Other: Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)

Study type: Interventional

Funder types: Other

Identifiers

NCT06672861

KCHRRF-KCDysQ-0014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with a Diagnosis of POTS, IST, or vasovagal syncope

Exclusion criteria

Patients with comorbid chronic conditions causing significant impairments in quality of life, defined as:

• NYHA Class III or IV Heart Failure
• COPD GOLD 3 or 4, Group C or D
• Any patients with current malignancy not in remission
• 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia Patients

Other group

Description:

Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia (Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), and Vasovagal syncope (VVS)) Patients

Treatment:

Other: Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)

Previously diagnosed/treated/undergone sinus node modification for Cardiac Dysautonomia Patients

Other group

Description:

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

Treatment:

Other: Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)