Clinical trial NCT06672861: Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)
Official title: Development and Validation of the Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) in Patients With Postural Orthostatic Tachycardia Syndrome, Inappropriate Sinus Tachycardia, and Other Disorders of Cardiac Dysautonomia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Dysautonomia
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
Collaborators: name: Kansas City Heart Rhythm Institute, Overland Park, KS
name: Midwest Heart and Vascular Specialists, Overland Park, KS
First posted: 2024-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: With the advent of other disease specific questionnaires in patients with cardiac disease such as the AFEQT questionnaire, patients with cardiac dysautonomia have a unique symptom set that can range from mild symptoms to debilitating on a daily scale. Given that they are an underdiagnosed population who often have considerable rates of misdiagnosis, diagnostic delay, and concurrent life limiting factors not addressed by previous QOL assessments, the next logical step therefore is the development and further validation of a QOL questionnaire that serves to respect and represent the 6 domains of QOL as stated by the WHO, with representation of all four health related QOL (HRQoL), as well as focus on underrepresented areas of patients with cardiac dysautonomia.

A novel disease specific KCDysQ questionnaire with questions being gathered from an extensive literature review of QOL measures in this subset of patients as well as interviews and personal interactions with these patients is proposed. It will begin with a 100-item questionnaire and proceed to use a power analysis to further stratify this. For validation of this questionnaire, it is proposed to prospectively recruit all patients with a diagnosis of POTS, IST, or VVS in a single center, and stratify them into patients with a new diagnosis/untreated POTS, IST, or VVS compared with patients who have had symptoms improvement with medication or stable disease who present for routine follow ups. Though an emerging technique and therefore a small but important percentage of this population, patients who have underwent sinus node manipulation for treatment of their IST or POTS as well will also be included, as these subsets of patients have undergone little prior evaluation.

Eligibility criteria: Inclusion criteria:

Patients with a Diagnosis of 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

Primary outcomes:
measure: To develop and validate KCDysQ as a quality of life and symptom severity assessment tool
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Overland Park
country: United States
facility: Midwest Heart and Vascular Specialists
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ptaszynski P, Kaczmarek K, Ruta J, Klingenheben T, Wranicz JK. Metoprolol succinate vs. ivabradine in the treatment of inappropriate sinus tachycardia in patients unresponsive to previous pharmacological therapy. Europace. 2013 Jan;15(1):116-21. doi: 10.1093/europace/eus204. Epub 2012 Jul 6.
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citation: Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15.