The Effect of RAAS Blockers on ACE2 Levels

NCT05418361 | Completed FDA Drug

• 1 other identifier: FAMASU/2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Blockage of renin-angiotensin-aldosterone system (RAAS) by angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs) is considered the first-choice of drugs for treatment of hypertension, heart failure and chronic kidney disease However, the interplay between RAAS blockers and ACE2 hasn't been fully elucidated SARS-CoV-2 is thought to infect host cells through ACE2 to cause coronavirus disease 2019 (COVID-19). Recent studies revealed that the spikes of COVID-19 could bind to the surface receptors of sensitive cells after contacting the airway surface, which may mediate virus entry into target cells and viral replication, and ACE2 might be a mediator of infection (South, Brady et al. 2020). Therefore, the imbalance in the RAAS, with a shift towards ACE/Ang II and suppression of ACE2/Ang-(1-7), may be an important mediator of COVID-19. To date, conflicting evidences were reported linking the use of RAAS blockers and the susceptibility to the virus. However, others showed that treatment with an RAAS blockers may downregulate the expression of ACE2 but have no significant effect on its activity This research importantly aimed to solve this important issue by determining the exact association between ARBs and ACE inhibitor and ACE2 activity and levels on clinical and experimental prospects.

Conditions

Renin-Angiotensin System

Outcome Measures

Primary Outcomes (1)

• Effect of RAAS blockers on ACE2 levels

  ACE2 levels in cardiovascular disease patients

  at least 6 months

Study Arms (3)

ACEIs group

Patients suffer from cardiovascular diseases)controlled hypertension or heart failure ) taking ACE inhibitors

Drug: ACE inhibitor ,angiotensin receptor blockers

ARBs group

Patients suffer from cardiovascular diseases)controlled hypertension or heart failure ) taking Angiotensin receptor blockers

Drug: ACE inhibitor ,angiotensin receptor blockers

healthy

matched healthy controls

Interventions

ACE inhibitor ,angiotensin receptor blockers DRUG

patients taking ACEI or ARBs with cardiovascular disease

ACEIs group; ARBs group

Eligibility Criteria

• Age: 43 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with controlled Hypertension or heart failure presenting to Cardiac Rehabilitation Units taking ACE inhibitors or AGII blockers

You may qualify if:

• Patients age\> 18 years
• Taking ACE II inhibitors or angiotensin II blockers (according to maximum tolerated dose specified by guidelines)
• History of essential hypertension or heart failure

You may not qualify if:

• patients who suffer from secondary hypertension, including idiopathic hyperaldosteronism, renal artery stenosis
• Patient reported history of severe liver disease
• a history or suspicion of alcohol or drug abuse; and mental illness
• Pregnant and breast feeding

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Select A State Or Province, 02, Egypt

Location

Related Publications (1)

• Farid Fahmy S, El Derany MO, Khorshid H, Saleh A, El-Demerdash E. Effect of renin angiotensin blockers on angiotensin converting enzyme 2 level in cardiovascular patients. BMC Pharmacol Toxicol. 2023 Apr 14;24(1):24. doi: 10.1186/s40360-023-00667-w.

  PMID: 37060024 DERIVED

Study Officials

• ebtehal el demerdash, prof

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 14, 2022
• Study Start: June 15, 2021
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: May 15, 2023

Record last verified: 2022-06

Locations

EG (1)