Questionnaire Development for Cardiac Dysautonomia

Recruiting at 2 trial locations

Overseen By Donita Atkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kansas City Heart Rhythm Research Foundation

Must not be taking: Steroids, Immunomodulators

Disqualifiers: Heart failure, COPD, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on questionnaires rather than medication changes.

What is the purpose of 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.

Research Team

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Eligibility Criteria

This trial is for individuals with cardiac dysautonomia, a condition affecting heart rate and autonomic nervous system function. Participants should have stable symptoms or be expected to experience changes in symptoms and quality of life.

Inclusion Criteria

I have been diagnosed with 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Questionnaire Development and Validation

Participants complete the KCDysQ questionnaire to assess quality of life and symptom severity

3 months

Follow-up

Participants are monitored for changes in symptoms and quality of life after completing the questionnaire

4 weeks

Treatment Details

Interventions

• Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)

Trial Overview The study is testing the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) against established questionnaires like SF-36 and EQ-5D to see how well it measures health outcomes in patients with cardiac dysautonomia.

Participant Groups

Group I: Previously diagnosed/treated/undergone sinus node modification for Cardiac Dysautonomia Patients Experimental Treatment 1 Intervention

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

Group II: Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia Patients Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Kansas City Heart Rhythm Research Foundation

Lead Sponsor

Trials

30

Recruited

14,000+

Kansas City Heart Rhythm Institute, Overland Park, KS

Collaborator

Trials

3

Recruited

210+

Midwest Heart and Vascular Specialists, Overland Park, KS

Collaborator

Trials

1

Recruited

100+