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Questionnaire Development for Cardiac Dysautonomia

N/A

Waitlist Available

Led By Dhanunjaya Lakkireddy

Research Sponsored by Kansas City Heart Rhythm Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

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 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare a new questionnaire for patients with cardiac dysautonomia to existing general questionnaires like SF-36 and EQ-5d. It will also compare these questionnaires in patients

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves completing questionnaires rather than taking medications or undergoing medical procedures, there are no direct physical side effects associated with participating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with POTS, IST, or vasovagal syncope.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To develop and validate KCDysQ as a quality of life and symptom severity assessment tool

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Previously diagnosed/treated/undergone sinus node modification for Cardiac Dysautonomia PatientsExperimental Treatment1 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 PatientsExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met