Developing a New Questionnaire for Cardiac Dysautonomia

This study is developing and testing a new questionnaire called the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ). This questionnaire aims to better understand the quality of life and symptoms for people with cardiac dysautonomia (a condition where the nervous system doesn't properly regulate heart function). Currently, there isn't a specific questionnaire for this condition, so researchers are comparing the KCDysQ to existing general health questionnaires. You might be able to join if you are 18 or older and have a diagnosis of POTS, IST, or vasovagal syncope. You cannot participate if you have certain severe chronic conditions like advanced heart failure or lung disease, or active cancer. The goal is to create a useful tool to assess how well patients are doing.

Study design
This interventional study plans to enroll 100 participants. It compares a new questionnaire to established ones.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of developing and validating the questionnaire is measured at 3 months.

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NCT06672861

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

Not Yet Recruiting
NAAges 18+Interventional
Kansas City Heart Rhythm Research Foundation
~100 participants
Updated 2025-08-28 on ClinicalTrials.gov
What's tested:Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To develop and validate KCDysQ as a quality of life and symptom severity assessment tool
Measured over 3 Months
Cardiac Dysautonomia
3 sites across 1 states
Kansas3
  • Dhanunjaya Lakkireddy · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute

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Eligibility criteria

Exclusion

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
  • To develop and validate KCDysQ as a quality of life and symptom severity assessment tool3 Months

    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.