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
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
46 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-10-01
Study Completion Date
2021-04-17
Brief Summary
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Coronavirus disease (COVID-19) related pneumonia significantly impact patients with underlying cardiovascular (CV) conditions. Animal studies suggest that drugs commonly used to treated CV diseases may increase the ability of COVID-19 to infect cells. The RAAS-COVID-19 trial aims to assess whether temporarily holding these CV drugs in patients who are admitted with COVID-19, versus continuing them, in patients admitted with COVID-19 can impact short term outcomes.
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Detailed Description
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Open-label, pragmatic, randomized, study of approximately 40 adults. The following groups of participants will be considered: i) within 48 hours of diagnosis of COVID-19; ii) who have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site (Royal Victoria Hospital, Montreal General Hospital, and Jewish General Hospital \[all in Montreal, Quebec, Canada\]). Participants will be randomized 1:1 to an upfront temporary discontinuation) of RAAS inhibition for the duration of the hospitalization (and to consider re-initiate after day 7 of admission or on discharge) versus a strategy continuation of RAAS inhibition. Re-initiation of held RAAS inhibition will be based on treating team's clinical judgement. The RAAS-COVID-19 RCT will evaluate whether an upfront strategy of temporary discontinuation of RAAS inhibition compared to the continuation of RAAS inhibition among patients admitted with established COVID-19 infection and on chronic RAAS inhibition therapy impacts short term clinical outcomes and biomarkers.
Conditions
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COVID-19
Cardiovascular Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Open-label, randomized, study of approximately 40 adults. The following groups of participants will be considered: i) within 48 hours of diagnosis of COVID-19; ii) who have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site (Royal Victoria Hospital, Montreal General Hospital, and Jewish General Hospital \[all in Montreal, Quebec, Canada\])). Participants will be randomized 1:1 to an upfront temporary discontinuation) of RAAS inhibition for the duration of the hospitalization (and to consider re-initiate on discharge) versus a strategy continuation of RAAS inhibition.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
The patient and the treating doctor will be informed of the assigned treatment.
Study Groups
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Intervention
Temporarily holding the RAAS inhibitor. Among participants who will be randomized to the intervention arm, a possible guideline-directed alternative to anti-hypertensive medication alternatives will be provided to the treating physician team.
Group Type
EXPERIMENTAL
Temporarily holding the RAAS inhibitor [intervention]
Intervention Type
OTHER
Temporarily holding the RAAS inhibitor. Among participants who will be randomized to the intervention arm, a possible guideline-directed alternative to anti-hypertensive medication alternatives will be provided to the treating physician team.
Continuation of standard of care
No intervention, Continuation RAAS inhibitor \[continued standard of care\].
Group Type
OTHER
RAAS inhibitor [continued standard of care]
Intervention Type
OTHER
No intervention, Continuation RAAS inhibitor \[continued standard of care\].
Interventions
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Temporarily holding the RAAS inhibitor [intervention]
Temporarily holding the RAAS inhibitor. Among participants who will be randomized to the intervention arm, a possible guideline-directed alternative to anti-hypertensive medication alternatives will be provided to the treating physician team.
Intervention Type
OTHER
RAAS inhibitor [continued standard of care]
No intervention, Continuation RAAS inhibitor \[continued standard of care\].
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old.
* Hospitalization with a Covid-19 infection
* Chronically treated with RAAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month
* Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample
* Participants are within 48 hours of diagnosis of COVID-19 or have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site
* Hospitalization with a Covid-19 infection
* Chronically treated with RAAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month
* Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample
* Participants are within 48 hours of diagnosis of COVID-19 or have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site
Exclusion Criteria
* Shock requiring vasoactive agents.
* Requiring invasive mechanical ventilation.
* History of malignant hypertension
* Use of five or more antihypertensive drugs.
* History of heart failure with reduced ejection fraction
* History of hospitalization for acute heart failure in past 3 months
* History of hospitalization for hemorrhagic stroke in the past 3 months.
* History of CKD with an eGFR \<45 ml/min/1.73m2
* History of COPD GOLD III/IV
* History of end-stage dementia
* History of active liver cirrhosis
* RAAS blockers therapy previously stopped \> 48h.
* Anticipated discharge in less than 24 hours.
* History of current active cancer receiving chemotherapy
* Inability to obtain informed consent.
* Requiring invasive mechanical ventilation.
* History of malignant hypertension
* Use of five or more antihypertensive drugs.
* History of heart failure with reduced ejection fraction
* History of hospitalization for acute heart failure in past 3 months
* History of hospitalization for hemorrhagic stroke in the past 3 months.
* History of CKD with an eGFR \<45 ml/min/1.73m2
* History of COPD GOLD III/IV
* History of end-stage dementia
* History of active liver cirrhosis
* RAAS blockers therapy previously stopped \> 48h.
* Anticipated discharge in less than 24 hours.
* History of current active cancer receiving chemotherapy
* Inability to obtain informed consent.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Jewish General Hospital (Montreal, Quebec, Canada)
UNKNOWN
Sponsor Role
collaborator
Montreal General Hospital (Montreal, Quebec, Canada)
UNKNOWN
Sponsor Role
collaborator
Université de Lorraine, Centre d'Investigation Clinique- Plurithématique Inserm
UNKNOWN
Sponsor Role
collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Sponsor Role
lead
Responsible Party
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Abhinav Sharma
Cardiologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Abhinav Sharma, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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Muhc-Rimuhc
Montreal, Quebec, Canada
Site Status
Countries
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Canada
References
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Vuille-dit-Bille RN, Camargo SM, Emmenegger L, Sasse T, Kummer E, Jando J, Hamie QM, Meier CF, Hunziker S, Forras-Kaufmann Z, Kuyumcu S, Fox M, Schwizer W, Fried M, Lindenmeyer M, Gotze O, Verrey F. Human intestine luminal ACE2 and amino acid transporter expression increased by ACE-inhibitors. Amino Acids. 2015 Apr;47(4):693-705. doi: 10.1007/s00726-014-1889-6. Epub 2014 Dec 23.
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Vaduganathan M, Vardeny O, Michel T, McMurray JJV, Pfeffer MA, Solomon SD. Renin-Angiotensin-Aldosterone System Inhibitors in Patients with Covid-19. N Engl J Med. 2020 Apr 23;382(17):1653-1659. doi: 10.1056/NEJMsr2005760. Epub 2020 Mar 30. No abstract available.
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Bavishi C, Maddox TM, Messerli FH. Coronavirus Disease 2019 (COVID-19) Infection and Renin Angiotensin System Blockers. JAMA Cardiol. 2020 Jul 1;5(7):745-747. doi: 10.1001/jamacardio.2020.1282. No abstract available.
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Zhang P, Zhu L, Cai J, Lei F, Qin JJ, Xie J, Liu YM, Zhao YC, Huang X, Lin L, Xia M, Chen MM, Cheng X, Zhang X, Guo D, Peng Y, Ji YX, Chen J, She ZG, Wang Y, Xu Q, Tan R, Wang H, Lin J, Luo P, Fu S, Cai H, Ye P, Xiao B, Mao W, Liu L, Yan Y, Liu M, Chen M, Zhang XJ, Wang X, Touyz RM, Xia J, Zhang BH, Huang X, Yuan Y, Loomba R, Liu PP, Li H. Association of Inpatient Use of Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers With Mortality Among Patients With Hypertension Hospitalized With COVID-19. Circ Res. 2020 Jun 5;126(12):1671-1681. doi: 10.1161/CIRCRESAHA.120.317134. Epub 2020 Apr 17.
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Guo J, Huang Z, Lin L, Lv J. Coronavirus Disease 2019 (COVID-19) and Cardiovascular Disease: A Viewpoint on the Potential Influence of Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers on Onset and Severity of Severe Acute Respiratory Syndrome Coronavirus 2 Infection. J Am Heart Assoc. 2020 Apr 7;9(7):e016219. doi: 10.1161/JAHA.120.016219. Epub 2020 Apr 1. No abstract available.
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Sun H, Davison BA, Cotter G, Pencina MJ, Koch GG. Evaluating treatment efficacy by multiple end points in phase II acute heart failure clinical trials: analyzing data using a global method. Circ Heart Fail. 2012 Nov;5(6):742-9. doi: 10.1161/CIRCHEARTFAILURE.112.969154. Epub 2012 Oct 11.
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Sharma A, Hijazi Z, Andersson U, Al-Khatib SM, Lopes RD, Alexander JH, Held C, Hylek EM, Leonardi S, Hanna M, Ezekowitz JA, Siegbahn A, Granger CB, Wallentin L. Use of Biomarkers to Predict Specific Causes of Death in Patients With Atrial Fibrillation. Circulation. 2018 Oct 16;138(16):1666-1676. doi: 10.1161/CIRCULATIONAHA.118.034125.
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Clerkin KJ, Fried JA, Raikhelkar J, Sayer G, Griffin JM, Masoumi A, Jain SS, Burkhoff D, Kumaraiah D, Rabbani L, Schwartz A, Uriel N. COVID-19 and Cardiovascular Disease. Circulation. 2020 May 19;141(20):1648-1655. doi: 10.1161/CIRCULATIONAHA.120.046941. Epub 2020 Mar 21.
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Nerenberg KA, Zarnke KB, Leung AA, Dasgupta K, Butalia S, McBrien K, Harris KC, Nakhla M, Cloutier L, Gelfer M, Lamarre-Cliche M, Milot A, Bolli P, Tremblay G, McLean D, Padwal RS, Tran KC, Grover S, Rabkin SW, Moe GW, Howlett JG, Lindsay P, Hill MD, Sharma M, Field T, Wein TH, Shoamanesh A, Dresser GK, Hamet P, Herman RJ, Burgess E, Gryn SE, Gregoire JC, Lewanczuk R, Poirier L, Campbell TS, Feldman RD, Lavoie KL, Tsuyuki RT, Honos G, Prebtani APH, Kline G, Schiffrin EL, Don-Wauchope A, Tobe SW, Gilbert RE, Leiter LA, Jones C, Woo V, Hegele RA, Selby P, Pipe A, McFarlane PA, Oh P, Gupta M, Bacon SL, Kaczorowski J, Trudeau L, Campbell NRC, Hiremath S, Roerecke M, Arcand J, Ruzicka M, Prasad GVR, Vallee M, Edwards C, Sivapalan P, Penner SB, Fournier A, Benoit G, Feber J, Dionne J, Magee LA, Logan AG, Cote AM, Rey E, Firoz T, Kuyper LM, Gabor JY, Townsend RR, Rabi DM, Daskalopoulou SS; Hypertension Canada. Hypertension Canada's 2018 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults and Children. Can J Cardiol. 2018 May;34(5):506-525. doi: 10.1016/j.cjca.2018.02.022. Epub 2018 Mar 1.
Reference Type
BACKGROUND
Sharma A, Elharram M, Afilalo J, Flannery A, Afilalo M, Tselios C, Ni J, Ezekowitz JA, Cheng MP, Ambrosy AP, Zannad F, Brophy JM, Giannetti N, Bessissow A, Kronfli N, Marelli A, Aziz H, Alqahtani M, Aflaki M, Craig M, Lopes RD, Ferreira JP. A randomized controlled trial of renin-angiotensin-aldosterone system inhibitor management in patients admitted in hospital with COVID-19. Am Heart J. 2022 May;247:76-89. doi: 10.1016/j.ahj.2022.01.015. Epub 2022 Feb 7.
Reference Type
DERIVED
Aflaki M, Flannery A, Ferreira JP, Cheng MP, Kronfli N, Marelli A, Zannad F, Brophy J, Afillalo J, Huynh T, Giannetti N, Bessissow A, Ezekowitz JA, Lopes RD, Ambrosy AP, Craig M, Sharma A. Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial. Trials. 2021 Feb 5;22(1):115. doi: 10.1186/s13063-021-05080-4.
Reference Type
DERIVED
Related Links
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https://digitalcommons.wayne.edu/cgi/viewcontent.cgi?article=2451&context=jmasm
Power and sample size estimation for nonparametric composite endpoints: Practical implementation using data simulations.
Other Identifiers
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MP-37-2021-6614
Identifier Type: -
Identifier Source: org_study_id
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