Arrhythmic Manifestations and Management in Hospitalized COVID-19 Patients

NCT ID: NCT04465552

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

666 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-10

Study Completion Date

2021-01-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronavirus Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hospitalized COVID-19 Patients

Patients received standard of care treatment during hospitalization

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients \> 18 years of age
* Hospital admission with COVID-19

Exclusion Criteria

● Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kansas City Heart Rhythm Research Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rakesh Gopinathannair, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City Heart Rhythm Research Foundation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

1. "Coronavirus Cases." Worldometer, www.worldometers.info/coronavirus/. Accessed March 28, 2020.

Reference Type BACKGROUND

2. "Covid-19 Interactive Map." Johns Hopkins Coronavirus Resource Center, 2020, coronavirus.jhu.edu/map.html. Accessed March 28, 2020.

Reference Type BACKGROUND

Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.

Reference Type BACKGROUND
PMID: 32015507 (View on PubMed)

4. Centers for Disease Control and Prevention. Interim Clinical Guidance for Management of Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) Infection, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html

Reference Type BACKGROUND

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

Reference Type BACKGROUND
PMID: 32031570 (View on PubMed)

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

Reference Type BACKGROUND
PMID: 32171076 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KCHRF-COVID-19-0001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Electrocardiographic Mapping and Imaging
NCT01394965 WITHDRAWN EARLY_PHASE1
Ventricular Tachycardia Mechanisms
NCT05478213 RECRUITING NA