HypertensionLOCHINVARNCT05087290
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
An observational study of Hypertension and Covid19, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The COVID-19 pandemic is the biggest medical challenge in decades. Individuals with pre-existing cardiovascular diseases have a higher risk of severe disease and death from COVID-19. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hypertension, Covid19
- What is being tested?
- Cases
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2021to 21 Sep 2023
- 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 30 to 60 years
- All sexes
- Adult
Study population: Patients admitted through Queen Elizabeth University Hospital (QEUH) receiving units with suspected/confirmed COVID-19 during 01/09/2020-31/12/2021 and who are alive at discharge. Clinically suspected COVID-19 should have either fever, new onset cough and/or anosmia/dysgeusia and/or ≥2 of the following presenting features (fatigue/generalised weakness, headache, myalgia, sore throat/coryzal symptoms, breathlessness, anorexia/nausea/vomiting, diarrhoea, contact with known COVID-19 positive case). OBELIX participants who have given consent previously will be re-contacted.
Who may be able to join
- Age 30-60 years
- Admission between 01/09/2020 - 31/12/2021
- Clinically suspected or Confirmed COVID-19 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test confirmed COVID-19 on admission
- No history of hypertension or current drug treatment for hypertension
- Controls
- Age 30-60
Show all 9Show fewer
- No history of hypertension
- No antihypertensive drugs
- Confirmed RT-PCR test negative and admission through Queen Elizabeth University Hospital immediate assessment unit and acute receiving units 01/09/2020 to 31/12/2021 or no history of SARS-CoV-2 infection or COVID-19
Who cannot join
- Inability to give informed consent/lack of capacity BMI >40 eGFR <60 ml/min Pregnancy History of
- Cancer within 5 years
- Persistent atrial fibrillation
- Severe illness, at investigator discretion Prescription of
- BP lowering drugs
- Oral Corticosteroid (chronic use)
- Immunosuppressive agents
- Oral NSAIDs (chronic use)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longer-term Effects of COVID-19 on Blood Vessels and Blood Pressure (LOCHINVAR) Phenotyping Study
The COVID-19 pandemic is the biggest medical challenge in decades. Individuals with pre-existing cardiovascular diseases have a higher risk of severe disease and death from COVID-19. The SARS-CoV-2 virus causes infection by targeting a molecule on the walls of the cells lining the lungs and the blood vessels leading to injury. There are concerns that after recovery from COVID-19, the damage sustained by these cells may have long-term consequences including high blood pressure, stroke and heart attacks. The burden of high blood pressure as a result of the pandemic is unknown and a greater understanding of COVID-19 impact on blood pressure and its underlying mechanisms is urgently needed.
LOCHINVAR is based on our pilot study "COVID-19 blood pressure endothelium interaction study" (OBELIX,NCT04409847, IRAS 284453), which found that patients with normal blood pressure at the time of hospital admission with COVID-19 showed a nine-point higher blood pressure ≥12 weeks after recovery, compared to a group without COVID-19. LOCHINVAR will extend the OBELIX study aiming to establish if COVID-19 increases the risk of developing high blood pressure and investigating underlying mechanisms through detailed measurements of blood pressure, blood vessel function, hormones and chemicals in the blood, urine and stool.
Read more
The investigators will invite 150 adults without pre-existing high blood pressure who were discharged from hospital after an admission: half with COVID-19 and half without. Baseline visit will be ≥12 weeks after discharge for measurements of blood pressure, tests of heart and blood vessel health, blood, urine and stool samples along with questionnaires on mood and quality of life. Two further study visits follow, at 12 and 18 months.
This study will generate crucial evidence on the long-term impact of COVID-19 on blood pressure along with information on potential mechanisms of this effect with immediate, transferable impact on clinical practice and inform risk mitigation measures.
Read the detailed description
The Coronavirus Disease-19 (COVID-19) pandemic is one of the biggest medical challenges in recent years. Whilst COVID-19 primarily affects the lungs, causing interstitial pneumonitis and severe acute respiratory distress syndrome, it also affects multiple organ systems, including the cardiovascular system(1-3). There are documented associations between severity of disease/mortality risk and advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer).(4,5) The most common complications include cardiac dysrhythmia(6,7), cardiac injury(8,9), myocarditis, heart failure, pulmonary embolism10 and disseminated intravascular coagulation(11).
The SARS-CoV-2 virus uses the ACE2 receptor (ACE2) to enter type 2 pneumocytes, macrophages, perivascular pericytes, and cardiomyocytes.(12) This may lead to myocardial dysfunction and damage, endothelial dysfunction, microvascular dysfunction, plaque instability, and myocardial infarction.(12) In addition, ACE2 is expressed in several other organs including cells lining the blood vessels (endothelial cells), ACE2 is a key player in the renin-angiotensin system (RAS) which is important in blood pressure regulation and is a target for some of the commonly used drugs used in the treatment of blood pressure. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers (ARBs) alter prognosis in those with COVID-19 infection.(12) Furthermore, there is evidence that the normally occurring bacteria in the gut (gut microbiome) directly influences the makeup of the human immune system and has been implicated in severity of COVID-19 as well as in the magnitude of the immune system response to SARS-CoV-2 infection(13).
This study (LOCHINVAR) is based on the pilot study "COVID-19 blood pressure endothelium interaction study" (OBELIX), funded by the Chief Scientific Office. Preliminary results showed that participants who had COVID-19 infection had an 8.6mmHg increase in their average 24hr systolic blood pressure, compared to those that did not have COVID-19 infection. The investigators will increase our recruitment of potential participants to meet our sample size of 150 participants (75 SARS-CoV-2 +ve cases and 75 SARS-CoV-2 -ve cases) built on OBELIX. This study will allow us to have a better understanding of the risks of developing high blood pressure or uncontrolled blood pressure following COVID-19 infection. This will allow doctors to be able to make a recommendation on the current/long term management of people with high blood pressure beyond the pandemic.
- Conditions
- Hypertension, Covid19
- Being tested
- Cases, Controls
- Keywords
- Hypertension, COVID-19
- Medical subject headings
- Hypertension, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CasesOther
All performed at baseline, 12 months and 18 months Medical and drug history Anthropometric tests Electrocardiogram Brachial flow mediated dilatation 6 minute walk test Blood sampling Urine sampling 24-hr Ambulatory Blood Pressure Monitor Questionnaires
Optional:
Stool sampling,24-hr Urine collection, Home Blood Pressure Monitor
ControlsOther
All performed at baseline, 12 months and 18 months Medical and drug history Anthropometric tests Electrocardiogram Brachial flow mediated dilatation 6 minute walk test Blood sampling Urine sampling 24-hr Ambulatory Blood Pressure Monitor Questionnaires
Optional:
Stool sampling,24-hr Urine collection, Home Blood Pressure Monitor
| Study group | Role | What they receive |
|---|---|---|
| Cases | SARS-CoV-2 +ve cases Receives: Other: Cases | |
| Control | SARS-CoV-2 -ve cases Receives: Other: Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour ABPM Systolic Blood Pressure
Average 24 hour Ambulatory Blood Pressure Monitoring - Systolic Blood Pressure , (all day and night) at 12 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
Measured: 12 months
Secondary outcomes (7)
24-hour ABPM Diastolic Blood Pressure
Average 24 hour Ambulatory Blood Pressure Monitoring - Diastolic Blood Pressure, 24hr (all day and night) at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
Measured: 12 months and 18 months
Day ABPM Systolic Blood Pressure
Day Ambulatory Blood Pressure Monitoring (Average Systolic Blood Pressure) 8 am to 8 pm at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
Measured: 12 months and 18 months
Day ABPM Diastolic Blood Pressure
Day Ambulatory Blood Pressure Monitoring (Average Diastolic Blood Pressure), 8 am to 8 pm at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
Measured: 12 months and 18 months
Night ABPM Systolic Blood Pressure
Night Ambulatory Blood Pressure Monitoring (Average Systolic Blood Pressure) 8pm to 8 am at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
Measured: 12 months and 18 months
Night ABPM Diastolic Blood Pressure
Night Ambulatory Blood Pressure Monitoring (Average Diastolic Blood Pressure) 8pm to 8 am at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
Measured: 12 months and 18 months
24-hour ABPM Heart Rate
24 hour Ambulatory Blood Pressure Monitoring - Heart Rate, 24hr (all day and night) at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
Measured: 12 months and 18 months
24-hour Urine Sodium
24-hour Urine Sodium at 12 months and 18 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
Measured: 12 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start30 Sep 2021
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandosh Padmanabhan, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087290
- Sponsor's protocol ID
- GN20CA501
- Other IDs
- 21/WS/0075, 299056, RG2690/21/24
- Acronym
- LOCHINVAR
- Status last verified
- Sep 2023
- First submitted
- 18 Oct 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
PubMed 32125452Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.
PubMed 32211816Huang 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.
PubMed 31986264Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19.
PubMed 32201335Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
PubMed 32320003Wang 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 32031570Liu K, Fang YY, Deng Y, Liu W, Wang MF, Ma JP, Xiao W, Wang YN, Zhong MH, Li CH, Li GC, Liu HG. Clinical characteristics of novel coronavirus cases in tertiary hospitals in Hubei Province. Chin Med J (Engl). 2020 May 5;133(9):1025-1031. doi: 10.1097/CM9.0000000000000744.
PubMed 32044814Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.
PubMed 32139904Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Prog Cardiovasc Dis. 2020 May-Jun;63(3):390-391. doi: 10.1016/j.pcad.2020.03.001. Epub 2020 Mar 10. No abstract available.
PubMed 32169400Danzi GB, Loffi M, Galeazzi G, Gherbesi E. Acute pulmonary embolism and COVID-19 pneumonia: a random association? Eur Heart J. 2020 May 14;41(19):1858. doi: 10.1093/eurheartj/ehaa254. No abstract available.
PubMed 32227120Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
PubMed 32073213Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, Madhur MS, Tomaszewski M, Maffia P, D'Acquisto F, Nicklin SA, Marian AJ, Nosalski R, Murray EC, Guzik B, Berry C, Touyz RM, Kreutz R, Wang DW, Bhella D, Sagliocco O, Crea F, Thomson EC, McInnes IB. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020 Aug 1;116(10):1666-1687. doi: 10.1093/cvr/cvaa106.
PubMed 32352535Segal JP, Mak JWY, Mullish BH, Alexander JL, Ng SC, Marchesi JR. The gut microbiome: an under-recognised contributor to the COVID-19 pandemic? Ther Adv Gastroenterol. 2020 Nov 24;13:1756284820974914. doi: 10.1177/1756284820974914. eCollection 2020.
PubMed 33281941Lip S, Tran TQB, Hanna R, Nichol S, Guzik TJ, Delles C, McClure J, McCallum L, Touyz RM, Berry C, Padmanabhan S. Long-term effects of SARS-CoV-2 infection on blood vessels and blood pressure - LOCHINVAR. J Hypertens. 2025 Jun 1;43(6):1057-1065. doi: 10.1097/HJH.0000000000004013. Epub 2025 Apr 10.
PubMed 40178227Lip S, Mccallum L, Delles C, McClure JD, Guzik T, Berry C, Touyz R, Padmanabhan S. Rationale and Design for the LOnger-term effects of SARS-CoV-2 INfection on blood Vessels And blood pRessure (LOCHINVAR): an observational phenotyping study. Open Heart. 2022 Jun;9(1):e002057. doi: 10.1136/openhrt-2022-002057.
PubMed 35750422
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longer-term Effects of COVID-19 on Blood Vessels and Blood Pressure (LOCHINVAR) Phenotyping Study
- ClinicalTrials.gov ID
- NCT05087290
- Acronym / sponsor ID
- LOCHINVAR / GN20CA501
- Conditions
- Hypertension, Covid19
- Keywords
- Hypertension, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 21 Oct 2021 (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.
The COVID-19 pandemic is the biggest medical challenge in decades. Individuals with pre-existing cardiovascular diseases have a higher risk of severe disease and death from COVID-19. The SARS-CoV-2 virus causes infection by targeting a molecule on the walls of the cells lining the lungs and the blood vessels leading to injury. There are concerns that after recovery from COVID-19, the damage sustained by these cells may have long-term consequences including high blood pressure, stroke and heart attacks. The burden of high blood pressure as a result of the pandemic is unknown and a greater understanding of COVID-19 impact on blood pressure and its underlying mechanisms is urgently needed.
LOCHINVAR is based on our pilot study "COVID-19 blood pressure endothelium interaction study" (OBELIX,NCT04409847, IRAS 284453), which found that patients with normal blood pressure at the time of hospital admission with COVID-19 showed a nine-point higher blood pressure ≥12 weeks after recovery, compared to a group without COVID-19. LOCHINVAR will extend the OBELIX study aiming to establish if COVID-19 increases the risk of developing high blood pressure and investigating underlying mechanisms through detailed measurements of blood pressure, blood vessel function, hormones and chemicals in the blood, urine and stool.
The investigators will invite 150 adults without pre-existing high blood pressure who were discharged from hospital after an admission: half with COVID-19 and half without. Baseline visit will be ≥12 weeks after discharge for measurements of blood pressure, tests of heart and blood vessel health, blood, urine and stool samples along with questionnaires on mood and quality of life. Two further study visits follow, at 12 and 18 months.
This study will generate crucial evidence on the long-term impact of COVID-19 on blood pressure along with information on potential mechanisms of this effect with immediate, transferable impact on clinical practice and inform risk mitigation measures.
Detailed description
The Coronavirus Disease-19 (COVID-19) pandemic is one of the biggest medical challenges in recent years. Whilst COVID-19 primarily affects the lungs, causing interstitial pneumonitis and severe acute respiratory distress syndrome, it also affects multiple organ systems, including the cardiovascular system(1-3). There are documented associations between severity of disease/mortality risk and advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer).(4,5) The most common complications include cardiac dysrhythmia(6,7), cardiac injury(8,9), myocarditis, heart failure, pulmonary embolism10 and disseminated intravascular coagulation(11).
The SARS-CoV-2 virus uses the ACE2 receptor (ACE2) to enter type 2 pneumocytes, macrophages, perivascular pericytes, and cardiomyocytes.(12) This may lead to myocardial dysfunction and damage, endothelial dysfunction, microvascular dysfunction, plaque instability, and myocardial infarction.(12) In addition, ACE2 is expressed in several other organs including cells lining the blood vessels (endothelial cells), ACE2 is a key player in the renin-angiotensin system (RAS) which is important in blood pressure regulation and is a target for some of the commonly used drugs used in the treatment of blood pressure. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers (ARBs) alter prognosis in those with COVID-19 infection.(12) Furthermore, there is evidence that the normally occurring bacteria in the gut (gut microbiome) directly influences the makeup of the human immune system and has been implicated in severity of COVID-19 as well as in the magnitude of the immune system response to SARS-CoV-2 infection(13).
This study (LOCHINVAR) is based on the pilot study "COVID-19 blood pressure endothelium interaction study" (OBELIX), funded by the Chief Scientific Office. Preliminary results showed that participants who had COVID-19 infection had an 8.6mmHg increase in their average 24hr systolic blood pressure, compared to those that did not have COVID-19 infection. The investigators will increase our recruitment of potential participants to meet our sample size of 150 participants (75 SARS-CoV-2 +ve cases and 75 SARS-CoV-2 -ve cases) built on OBELIX. This study will allow us to have a better understanding of the risks of developing high blood pressure or uncontrolled blood pressure following COVID-19 infection. This will allow doctors to be able to make a recommendation on the current/long term management of people with high blood pressure beyond the pandemic.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: CasesSARS-CoV-2 +ve cases |
| Control | – | Other: ControlsSARS-CoV-2 -ve cases |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients admitted through Queen Elizabeth University Hospital (QEUH) receiving units with suspected/confirmed COVID-19 during 01/09/2020-31/12/2021 and who are alive at discharge. Clinically suspected COVID-19 should have either fever, new onset cough and/or anosmia/dysgeusia and/or ≥2 of the following presenting features (fatigue/generalised weakness, headache, myalgia, sore throat/coryzal symptoms, breathlessness, anorexia/nausea/vomiting, diarrhoea, contact with known COVID-19 positive case). OBELIX participants who have given consent previously will be re-contacted.
Key inclusion criteria (9 listed)
- Age 30-60 years
- Admission between 01/09/2020 - 31/12/2021
- Clinically suspected or Confirmed COVID-19 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test confirmed COVID-19 on admission
- No history of hypertension or current drug treatment for hypertension
- Controls
Key exclusion criteria (8 listed)
- Inability to give informed consent/lack of capacity BMI >40 eGFR <60 ml/min Pregnancy History of
- Cancer within 5 years
- Persistent atrial fibrillation
- Severe illness, at investigator discretion Prescription of
- BP lowering drugs
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 |
|---|---|---|
| CasesAll performed at baseline, 12 months and 18 months Medical and drug history Anthropometric tests Electrocardiogram Brachial flow mediated dilatation 6 minute walk test Blood sampling Urine sampling 24-hr Ambulatory Blood Pressure Monitor Questionnaires Optional: Stool sampling,24-hr Urine collection, Home Blood Pressure Monitor | Other | Cases |
| ControlsAll performed at baseline, 12 months and 18 months Medical and drug history Anthropometric tests Electrocardiogram Brachial flow mediated dilatation 6 minute walk test Blood sampling Urine sampling 24-hr Ambulatory Blood Pressure Monitor Questionnaires Optional: Stool sampling,24-hr Urine collection, Home Blood Pressure Monitor | Other | Control |
Primary outcome
24-hour ABPM Systolic Blood Pressure
Time frame: 12 months
Average 24 hour Ambulatory Blood Pressure Monitoring - Systolic Blood Pressure , (all day and night) at 12 months in SARS-CoV-2 +ve cases and in SARS-CoV-2 -ve controls
7 secondary outcomes
24-hour ABPM Diastolic Blood Pressure
Time frame: 12 months and 18 months
Day ABPM Systolic Blood Pressure
Time frame: 12 months and 18 months
Day ABPM Diastolic Blood Pressure
Time frame: 12 months and 18 months
Night ABPM Systolic Blood Pressure
Time frame: 12 months and 18 months
Night ABPM Diastolic Blood Pressure
Time frame: 12 months and 18 months
24-hour ABPM Heart Rate
Time frame: 12 months and 18 months
24-hour Urine Sodium
Time frame: 12 months and 18 months
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 26 Sep 2023.
- Background: PubMed 32125452Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
- Background: PubMed 32211816Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.
- Background: PubMed 31986264Huang 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.
- Background: PubMed 32201335Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19.
- Background: PubMed 32320003Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
- 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 32044814Liu K, Fang YY, Deng Y, Liu W, Wang MF, Ma JP, Xiao W, Wang YN, Zhong MH, Li CH, Li GC, Liu HG. Clinical characteristics of novel coronavirus cases in tertiary hospitals in Hubei Province. Chin Med J (Engl). 2020 May 5;133(9):1025-1031. doi: 10.1097/CM9.0000000000000744.
- Background: PubMed 32139904Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.
- Background: PubMed 32169400Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Prog Cardiovasc Dis. 2020 May-Jun;63(3):390-391. doi: 10.1016/j.pcad.2020.03.001. Epub 2020 Mar 10. No abstract available.
- Background: PubMed 32227120Danzi GB, Loffi M, Galeazzi G, Gherbesi E. Acute pulmonary embolism and COVID-19 pneumonia: a random association? Eur Heart J. 2020 May 14;41(19):1858. doi: 10.1093/eurheartj/ehaa254. No abstract available.
- Background: PubMed 32073213Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
- Background: PubMed 32352535Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, Madhur MS, Tomaszewski M, Maffia P, D'Acquisto F, Nicklin SA, Marian AJ, Nosalski R, Murray EC, Guzik B, Berry C, Touyz RM, Kreutz R, Wang DW, Bhella D, Sagliocco O, Crea F, Thomson EC, McInnes IB. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020 Aug 1;116(10):1666-1687. doi: 10.1093/cvr/cvaa106.
- OBELIX StudyLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension and Covid19, run by University of Glasgow at 1 site in United Kingdom.
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 9 inclusion and 8 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 26 Sep 2023. 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 Kingdom. 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?
24-hour ABPM Systolic Blood Pressure (time frame: 12 months). 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 NCT05087290, which also lists 15 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 26 Sep 2023.