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

NCT04364893 | Unknown DMC

• 1 other identifier: PRJ_2003
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Corona Virus Infection; COVID-19

Keywords

Blockers of angiotensin receptor; Angiotensin-converting enzyme inhibitors; SARS-CoV2

Outcome Measures

Primary Outcomes (1)

• Median days alive and out of the hospital

  The primary outcome of the study will be days alive and outside the hospital (DAOH) at 30 days. This endpoint will be calculated for each included patient and the calculation will be from the date of randomization to the 30-day post-randomization. The DAOH endpoint represents the follow-up time (30 days) subtracted from the hospitalization days and/or the days between death and the end of follow-up.

  30 days

Secondary Outcomes (2)

• Number of participants with adverse cardiovascular outcomes and new worsening heart failure

  30 days

• Cardiovascular biomarkers related to COVID-19

  up to 30 days

Study Arms (2)

Group 1

OTHER

Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

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

Group 2

OTHER

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

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

Interventions

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

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead
• Brazilian Clinical Research Institute: collaborator

Study Sites (1)

Idor

São Paulo, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 35405099 DERIVED

• 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.

  PMID: 33464336 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Suspensions; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Renato D. Lopes, MD, PhD

  D'Or Institute for Research and Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato D. Lopes, MD, PhD

CONTACT

55 11 5904 7339; renato.lopes@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 28, 2020
• Study Start: April 9, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-07

Locations

BR (1)