Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Patients With COVID19

NCT ID: NCT04364893

Last Updated: 2020-07-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-09

Study Completion Date

2020-12-01

Brief Summary

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Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.

Detailed Description

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Several interactions by pre-existing therapies for chronic diseases, therapies used by SARS-CoV2 infection generate doubts about risks and benefits. Among these situations in which the current data indicate a situation of equipoise would be about the maintenance or suspension of ACEI / BRA in patients with SARS-CoV2 infection. Increasing the expression of ECA-2 could increase the binding to the virus, however, there are studies that indicate this increase in ECA-2 could be protective. So far, there is no clinical evidence to confirm any of the theories, and this question can only be clarified through a randomized clinical trial.

The objective is to evaluate the impact of the suspension of the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (BRA) on the length of hospital stay and on the mortality of patients with SARS-CoV2 infection.

Conditions

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Corona Virus Infection COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Group Type OTHER

Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Intervention Type OTHER

Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Group 2

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Group Type OTHER

Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Intervention Type OTHER

Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Interventions

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Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients hospitalized with COVID-19 diagnosis using ACE inhibitors or blockers of angiotensin receptor;
* Patients ≥ 18 years old;
* Maximum use of 3 antihypertensive drugs;
* Sign the consent form.

Exclusion Criteria

* Severe evolution with orotracheal intubation, use of mechanical ventilation and / or hemodynamic instability in the first 24 hours until COVID-19 diagnosis confirmation;
* Patients hospitalized per decompensated congestive heart failure in the last 12 months;
* Use of Sacubitril/Valsartan
* Pregnancy
* Recent acute renal failure and shock
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brazilian Clinical Research Institute

OTHER

Sponsor Role collaborator

D'Or Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renato D. Lopes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

D'Or Institute for Research and Education

Locations

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Idor

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Renato D. Lopes, MD, PhD

Role: CONTACT

55 11 5904 7339

Facility Contacts

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Renato D. Lopes, MD, PhD

Role: primary

References

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Macedo AVS, de Barros E Silva PGM, de Paula TC, Moll-Bernardes RJ, Mendonca Dos Santos T, Mazza L, Feldman A, Arruda GDAS, de Albuquerque DC, de Sousa AS, de Souza OF, Gibson CM, Granger CB, Alexander JH, Lopes RD. Discontinuing vs continuing ACEIs and ARBs in hospitalized patients with COVID-19 according to disease severity: Insights from the BRACE CORONA trial. Am Heart J. 2022 Jul;249:86-97. doi: 10.1016/j.ahj.2022.04.001. Epub 2022 Apr 8.

Reference Type DERIVED
PMID: 35405099 (View on PubMed)

Lopes RD, Macedo AVS, de Barros E Silva PGM, Moll-Bernardes RJ, Dos Santos TM, Mazza L, Feldman A, D'Andrea Saba Arruda G, de Albuquerque DC, Camiletti AS, de Sousa AS, de Paula TC, Giusti KGD, Domiciano RAM, Noya-Rabelo MM, Hamilton AM, Loures VA, Dionisio RM, Furquim TAB, De Luca FA, Dos Santos Sousa IB, Bandeira BS, Zukowski CN, de Oliveira RGG, Ribeiro NB, de Moraes JL, Petriz JLF, Pimentel AM, Miranda JS, de Jesus Abufaiad BE, Gibson CM, Granger CB, Alexander JH, de Souza OF; BRACE CORONA Investigators. Effect of Discontinuing vs Continuing Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers on Days Alive and Out of the Hospital in Patients Admitted With COVID-19: A Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):254-264. doi: 10.1001/jama.2020.25864.

Reference Type DERIVED
PMID: 33464336 (View on PubMed)

Other Identifiers

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PRJ_2003

Identifier Type: -

Identifier Source: org_study_id

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