Coronavirus InfectionsNCT04465552
Arrhythmic Manifestations and Management in Hospitalized COVID-19 Patients
An observational study of Coronavirus Infections, run by Kansas City Heart Rhythm Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections
- How many people
- 666 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2020to 24 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized COVID-19 patients > 18 years of age
Who may be able to join
- Patients > 18 years of age
- Hospital admission with COVID-19
Who cannot join
- ● Age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
About this study
Official title: Arrhythmic Manifestations and Management Strategies in Hospitalized COVID-19 Patients: Proposal for a Multicenter Registry
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.
Read the 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.
- Conditions
- Coronavirus Infections
- Being tested
- Patients received standard of care treatment during hospitalization
- Keywords
- COVID-19, Arrhythmic Manifestations, Management Strategies
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients received standard of care treatment during hospitalizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized COVID-19 Patients | Not described Receives: Other: Patients received standard of care treatment during hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: January 1, 2020 - June 30, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start10 Jul 2020
- Primary completion24 Jan 2021
- Study completion24 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rakesh Gopinathannair, MD, Principal investigator, Kansas City Heart Rhythm Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465552
- Sponsor's protocol ID
- KCHRF-COVID-19-0001
- Status last verified
- Sep 2021
- First submitted
- 9 Jul 2020
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. "Coronavirus Cases." Worldometer, www.worldometers.info/coronavirus/. Accessed March 28, 2020.
2. "Covid-19 Interactive Map." Johns Hopkins Coronavirus Resource Center, 2020, coronavirus.jhu.edu/map.html. Accessed March 28, 2020.
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.
PubMed 320155074. 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
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.
PubMed 32031570Zhou 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.
PubMed 32171076
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrhythmic Manifestations and Management Strategies in Hospitalized COVID-19 Patients: Proposal for a Multicenter Registry
- ClinicalTrials.gov ID
- NCT04465552
- Acronym / sponsor ID
- KCHRF-COVID-19-0001
- Conditions
- Coronavirus Infections
- Keywords
- COVID-19, Arrhythmic Manifestations, Management Strategies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 24 Jan 2021 (actual)
- Study completion
- 24 Jan 2021 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized COVID-19 Patients | – | Other: Patients received standard of care treatment during hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized COVID-19 patients > 18 years of age
Key inclusion criteria (2 listed)
- Patients > 18 years of age
- Hospital admission with COVID-19
Key exclusion criteria (1 listed)
- ● Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients received standard of care treatment during hospitalizationAll 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. | Other | Hospitalized COVID-19 Patients |
Primary outcome
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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Background1. "Coronavirus Cases." Worldometer, www.worldometers.info/coronavirus/. Accessed March 28, 2020.
- Background2. "Covid-19 Interactive Map." Johns Hopkins Coronavirus Resource Center, 2020, coronavirus.jhu.edu/map.html. Accessed March 28, 2020.
- Background: PubMed 32015507Zhou 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.
- Background4. 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
- Background: PubMed 32031570Wang 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.
- Background: PubMed 32171076Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh Gopinathannair, MD principal investigator
Kansas City Heart Rhythm Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections, run by Kansas City Heart Rhythm Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: January 1, 2020 - June 30, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04465552, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.