Arrhythmic Manifestations and Management in Hospitalized COVID-19 Patients

Sponsor
Kansas City Heart Rhythm Research Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT04465552
Collaborator
(none)
666
1
6.5
102.4

Study Details

Study Description

Brief Summary

Although arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and predictors, therapeutic strategies employed as well as long term outcomes are not well understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations, employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in the US.

Condition or Disease Intervention/Treatment Phase
  • Other: Patients received standard of care treatment during hospitalization

Detailed Description

The novel coronavirus (SARS-CoV-2) and the resulting respiratory tract infection (Coronavirus Disease 2019 or COVID-19) is a pandemic with over 3 million cases globally and resulting in

230,000 deaths at the time of this writing. From initial reports in Wuhan, China, viral progression resulted in over 80,000 cases in January/February 2020 in China. The following global spread has involved more than 210 countries. Unfortunately, the United States has been significantly affected, with over 1 million confirmed cases and over 60,000 deaths, the highest in the world. As this global pandemic continues to rage, cardiovascular, especially arrhythmic manifestations associated with COVID-19 have become evident. A recent report from Wuhan, China, noted that 16.7% of hospitalized and 44.4% of ICU patients with COVID-19 had arrhythmias. Although arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and predictors, therapeutic strategies employed as well as long term outcomes are not well understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations, employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in the US.

Study Design

Study Type:
Observational
Actual Enrollment :
666 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Arrhythmic Manifestations and Management Strategies in Hospitalized COVID-19 Patients: Proposal for a Multicenter Registry
Actual Study Start Date :
Jul 10, 2020
Actual Primary Completion Date :
Jan 24, 2021
Actual Study Completion Date :
Jan 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Hospitalized COVID-19 Patients

Other: Patients received standard of care treatment during hospitalization
All patients admitted with covid-19 will be enrolled and followed for the duration of their hospitalization as well as during outpatient follow for up to 6 months, in those recovered, to assess clinical outcomes.

Outcome Measures

Primary Outcome Measures

  1. To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review. [January 1, 2020 - June 30, 2020]

    To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients > 18 years of age

  • Hospital admission with COVID-19

Exclusion Criteria:

● Age < 18 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kansas City Heart Rhythm Institute Overland Park Kansas United States 66211

Sponsors and Collaborators

  • Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Rakesh Gopinathannair, MD, Kansas City Heart Rhythm Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kansas City Heart Rhythm Research Foundation
ClinicalTrials.gov Identifier:
NCT04465552
Other Study ID Numbers:
  • KCHRF-COVID-19-0001
First Posted:
Jul 10, 2020
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kansas City Heart Rhythm Research Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2021