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

ConditionCardiac Dysautonomia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorKansas City Heart Rhythm Research Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)
Other intervention
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia PatientsOther 1 intervention

Group B: Previously diagnosed/treated/undergone sinus node modification for Cardiac Dysautonomia PatientsOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

3 Months

Sponsors and contacts

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Kansas City Heart Rhythm Research Foundation

Lead sponsor

Kansas City Heart Rhythm Institute

Collaborator

Midwest Heart and Vascular Specialists, Overland Park, KS

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: