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

NCT06672861 | Not Yet Recruiting

• 1 other identifier: KCHRRF-KCDysQ-0014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiac Dysautonomia

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 Months

Study Arms (2)

Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia Patients

OTHER

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

Other: Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)

Previously diagnosed/treated/undergone sinus node modification for Cardiac Dysautonomia Patients

OTHER

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

Other: Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ)

Interventions

Kansas City Cardiac Dysautonomia Questionnaire (KCDysQ) OTHER

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.

Newly diagnosed/untreated/incompletely treated for Cardiac Dysautonomia Patients; Previously diagnosed/treated/undergone sinus node modification for Cardiac Dysautonomia Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead
• Kansas City Heart Rhythm Institute, Overland Park, KS: collaborator
• Midwest Heart and Vascular Specialists, Overland Park, KS: collaborator

Study Sites (3)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Midwest Heart and Vascular Specialists

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

Related Publications (9)

• Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available.

  PMID: 25980576 BACKGROUND

• Abed HS, Fulcher JR, Kilborn MJ, Keech AC. Inappropriate sinus tachycardia: focus on ivabradine. Intern Med J. 2016 Aug;46(8):875-83. doi: 10.1111/imj.13093.

  PMID: 27059112 BACKGROUND

• Shaw BH, Stiles LE, Bourne K, Green EA, Shibao CA, Okamoto LE, Garland EM, Gamboa A, Diedrich A, Raj V, Sheldon RS, Biaggioni I, Robertson D, Raj SR. The face of postural tachycardia syndrome - insights from a large cross-sectional online community-based survey. J Intern Med. 2019 Oct;286(4):438-448. doi: 10.1111/joim.12895. Epub 2019 Apr 16.

  PMID: 30861229 BACKGROUND

• Bagai K, Song Y, Ling JF, Malow B, Black BK, Biaggioni I, Robertson D, Raj SR. Sleep disturbances and diminished quality of life in postural tachycardia syndrome. J Clin Sleep Med. 2011 Apr 15;7(2):204-10.

  PMID: 21509337 BACKGROUND

• Benrud-Larson LM, Dewar MS, Sandroni P, Rummans TA, Haythornthwaite JA, Low PA. Quality of life in patients with postural tachycardia syndrome. Mayo Clin Proc. 2002 Jun;77(6):531-7. doi: 10.4065/77.6.531.

  PMID: 12059122 BACKGROUND

• Raj SR. Postural tachycardia syndrome (POTS). Circulation. 2013 Jun 11;127(23):2336-42. doi: 10.1161/CIRCULATIONAHA.112.144501. No abstract available.

  PMID: 23753844 BACKGROUND

• 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.

  PMID: 22772053 BACKGROUND

• Fedorowski A. Postural orthostatic tachycardia syndrome: clinical presentation, aetiology and management. J Intern Med. 2019 Apr;285(4):352-366. doi: 10.1111/joim.12852. Epub 2018 Nov 23.

  PMID: 30372565 BACKGROUND

• 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.

  PMID: 21160035 BACKGROUND

Study Officials

• Dhanunjaya Lakkireddy

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: November 4, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)