Questionnaire Development for Cardiac Dysautonomia

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new questionnaire specifically designed for individuals with cardiac dysautonomia, a condition affecting heart rate and blood pressure regulation. The goal is to evaluate how well the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) performs compared to existing questionnaires in assessing quality of life and symptoms. Participants will include those newly diagnosed or experiencing ongoing symptoms of conditions such as Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), or Vasovagal Syncope (VVS). Individuals with these conditions who have not found complete relief from treatment may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to the development of improved assessment tools for cardiac dysautonomia.

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 prior data suggests that the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) is safe for use in patients?

Research shows that the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) is being developed to measure the impact of cardiac dysautonomia on people's lives and symptoms. This is not a treatment like a medicine but a tool to help doctors and researchers understand how these conditions affect daily life.

As the KCDysQ is merely a questionnaire, it does not cause physical side effects like medication might. The primary goal is to assess how effectively it captures symptoms and quality of life. So far, studies have not identified any issues with using this questionnaire. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) because it aims to provide a more precise assessment of symptoms for patients with cardiac dysautonomia conditions like POTS, IST, and VVS. Unlike current clinical assessments, which can be subjective and inconsistent, this new questionnaire is designed to capture a comprehensive range of symptoms and their impact on daily life. By offering a standardized tool, KCDysQ may lead to better-tailored treatment plans and improved patient outcomes.

What evidence suggests that the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) is effective for assessing cardiac dysautonomia?

The Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) is designed to assess quality of life and symptom severity in individuals with heart-related autonomic nervous system disorders. These include conditions like Postural Orthostatic Tachycardia Syndrome (POTS), Inappropriate Sinus Tachycardia (IST), and Vasovagal Syncope (VVS). Unlike general questionnaires such as the SF-36 and EQ-5D, the KCDysQ specifically targets these conditions. Although still in testing, the KCDysQ aims to clarify the daily challenges faced by those with these disorders. Understanding these challenges better could lead to improved treatments in the future. ^{1 2 4 6 7}

Who Is on the Research Team?

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06672861?term=AREA%5BBasicSearch%5D(Dysautonomia)&rank=4

Development and Validation of the Kansas City Cardiac ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06672861

Development and Validation of the Kansas City Cardiac ... 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 ...

3. malacards.org malacards.org/card/postural_orthostatic_tachycardia_syndrome

Postural Orthostatic Tachycardia Syndrome Postural orthostatic tachycardia syndrome (POTS) is a rare genetic disorder caused by a deficiency in the norepinephrine transporter, leading to high plasma ...

4. withpower.com withpower.com/trial/phase-primary-dysautonomias-3-2025-a6851

Questionnaire Development for Cardiac Dysautonomia Trial Overview The study is testing the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) against established questionnaires like SF-36 and EQ-5D to see ...

5. synapse.patsnap.com synapse.patsnap.com/disease/d34e2b0c80884a11b97303cdcf59e9fa

Tachycardia, Supraventricular - Drugs, Targets, Patents Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) in Patients With Postural Orthostatic Tachycardia Syndrome ...

6. sigma.larvol.com sigma.larvol.com/facility.php?e1=22651&e2=&FacilityId=22651&tab=FacilityOTT&sr=now&er=1+month&ipwnd=on&rlink=,FacilityId=22651,itype=0,1&rflag=1&page=2

Kansas University Medical Center Trials Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ). Kansas City Heart Rhythm Research Foundation, Kansas City Heart Rhythm Institute, Overland Park, KS ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40908080/

Minimally Important Kansas City Cardiomyopathy ... The overall KCCQ-OSS MCIDs for improvement or deterioration was 3.9 (95% CI: 2.7-5.4), with similar results for the KCCQ-CSS. Conclusions: A 5-point difference ...