- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04318301
Hypertension in Patients Hospitalized With COVID-19 (HT-COVID19)
April 28, 2020 updated by: Zhenhua Zen
Hypertension in Patients Hospitalized With COVID-19 in Wuhan, China: A Single-center Retrospective Observational Study
Some studies have shown that the main pathogenesis of patients with covid19 is related to ACE2 receptor.
Lung is one of the main organs, and there are many ACE2 receptors in cardiovascular system.
ACEI / ARB is the main target of antihypertensive drugs.
Previous reports suggested that there were large number of patients with covid19 also suffered from hypertension, suggesting that patients with hypertension may be the susceptible to covid19.
Therefore, we try to follow up the patients admitted to Hankou hospital to explore the impact of hypertension and hypertension treatment on the severity and prognosis of patients with covid19, so as to provide new methods for the treatment of patients with covid19 in the future.
Study Overview
Status
Completed
Conditions
Detailed Description
In December, 2019, a cluster of severe pneumonia cases of unknown cause emerged in Wuhan, China, with clinical presentations greatly resembling viral pneumonia1.
Deep sequencing analysis from lower respiratory tract samples indicated a novel coronavirus, which was named 2019 novel coronavirus (2019-nCoV, then named COVID-19).
Up to Mar 16, 2020, the total number of patients had risen sharply to 153,546 confirmed cases worldwide (http://2019ncov.chinacdc.cn/2019-nCoV/global.html).
The data extracted from 1099 patients with laboratory-confirmed COVID-19 in China from January 29, 2020 showed that hypertension is the most common coexisting illness of COVID-19 patients, ranging from 13.4% in nonsevere patient vs. 23.4% in severe patients, and the total incidence is as high as 15%2.
Interestingly, ACE2 is involved in the pathogenesis of both hypertension and SARS-COV-2 pneumonia.
The above reasons prompted us to speculate that the organs attacked by SARS-COV-2 might not only be lungs, but also include other ACE2 expression organs, especially cardiovascular system.
In addition, patients with comorbid hypertension, especially those with long-term oral ACEI/ARB medication for hypertension, might have different susceptibility and severity levels of pneumonia upon SARS-COV-2 attack.
Therefore, we investigated and compared the demographic characteristics, coexisting disease, severity of pneumonia, and the effect of antihypertensive drugs (ACEI/ARB versus non-ACEI/ARB) in patients with COVID-19 coexisting hypertension, thereby, hopefully, to reduce the mortality and morbidity associated with hypertension in patients with COVID-19.
Study Type
Observational
Enrollment (Actual)
275
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Hankou, Hubei, China, 430000
- Hankou Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with clinically confirmed COVID-19 admitted to Hankou Hospital, Wuhan, China from January 5 to March 8, 2020.
Description
Inclusion Criteria:
- COVID-19 pneumonia patients diagnosed by WHO criteria
Exclusion Criteria:
- Patients who were younger than 18 years.
- Patients whose entire stay lasted for less than 48 hours.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
ACEI/ARB
COVID-19 patients with hypertension who had previously taken ACEI/ARB for antihypertensive treatment
|
non ACEI/ARB
COVID-19 patients with hypertension who had not previously taken ACEI/ARB for antihypertensive treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Death
Time Frame: From date of admission until the date of death from any cause, up to 60 days
|
mortality in 28-day
|
From date of admission until the date of death from any cause, up to 60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the severity of pneumonia
Time Frame: From date of admission until the date of discharge or death from any cause, up to 60 days
|
evaluate the severity of pneumonia according to CT scans and clinical manifestation
|
From date of admission until the date of discharge or death from any cause, up to 60 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the length of hospital stay
Time Frame: From date of admission until the date of discharge or death from any cause, up to 60 days
|
days from admission to discharge or death
|
From date of admission until the date of discharge or death from any cause, up to 60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
- Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- Ferrario CM, Jessup J, Chappell MC, Averill DB, Brosnihan KB, Tallant EA, Diz DI, Gallagher PE. Effect of angiotensin-converting enzyme inhibition and angiotensin II receptor blockers on cardiac angiotensin-converting enzyme 2. Circulation. 2005 May 24;111(20):2605-10. doi: 10.1161/CIRCULATIONAHA.104.510461. Epub 2005 May 16.
- Li W, Moore MJ, Vasilieva N, Sui J, Wong SK, Berne MA, Somasundaran M, Sullivan JL, Luzuriaga K, Greenough TC, Choe H, Farzan M. Angiotensin-converting enzyme 2 is a functional receptor for the SARS coronavirus. Nature. 2003 Nov 27;426(6965):450-4. doi: 10.1038/nature02145.
- Wang Z, Chen Z, Zhang L, Wang X, Hao G, Zhang Z, Shao L, Tian Y, Dong Y, Zheng C, Wang J, Zhu M, Weintraub WS, Gao R; China Hypertension Survey Investigators. Status of Hypertension in China: Results From the China Hypertension Survey, 2012-2015. Circulation. 2018 May 29;137(22):2344-2356. doi: 10.1161/CIRCULATIONAHA.117.032380. Epub 2018 Feb 15.
- Turner AJ, Hiscox JA, Hooper NM. ACE2: from vasopeptidase to SARS virus receptor. Trends Pharmacol Sci. 2004 Jun;25(6):291-4. doi: 10.1016/j.tips.2004.04.001.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2020
Primary Completion (Actual)
March 28, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
March 20, 2020
First Submitted That Met QC Criteria
March 20, 2020
First Posted (Actual)
March 23, 2020
Study Record Updates
Last Update Posted (Actual)
April 29, 2020
Last Update Submitted That Met QC Criteria
April 28, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HT-COVID19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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