Effect of Renin Angiotensin Aldosterone System Genetic Polymorphism on the Pharmacological Effect of Mineralocorticoid Receptor Antagonists in Patients With Myocardial Infarction

Recruiting

• Conditions: Myocardial Infarction

• Registration Number: NCT05873400
• Lead Sponsor: Ain Shams University

Brief Summary

Early treatment of Myocardial Infarction patients with mineralocorticoid receptor antagonist with help reduces the incidence of cardiac remodeling and development into heart failure. Also studying aldosterone synthase (CYP11B2) and mineralocorticoid receptor (NR3C2) gene polymorphisms in Egyptian Myocardial Infarction patients will help tailor medication therapy and optimize therapeutic effects with the least adverse effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24
• Primary Completion: 2023-12-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• ST- segment elevation patients.
• Patients who are candidate for add-on treatment with Mineralocorticoid receptor antagonists (MRAs) to improve cardiac remodeling.
• Age of 18 years to 80 years.
• Written informed consent of the subject to participate in the study.

Exclusion Criteria

• Contraindications to Mineralocorticoid receptor antagonists (MRA) including: serum potassium >5.5 mEq/L at initiation; CrCl ≤30 mL/minute; concomitant use of strong CYP3A4 inhibitors; concomitant use with potassium supplements or potassium-sparing diuretics.
• Mild-to-severe valvular stenosis or severe (grade III/IV) valvular regurgitation
• Pregnant or nursing women.
• Non cardiac disorders associated with increased growth factor (e.g., HIV, Alzheimer, Crohn's disease, Cancer, glomerulonephritis, glomerulosclerosis, diabetic nephropathy, muscle atrophy, fibrotic conditions and burns).
• Patients with chronic heart failure with reduced ejection fraction (LVEF <40%).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic polymorphism	3 months	To investigate impact of genetic polymorphism in aldosterone synthase (CYP11B2), mineralocorticoid receptor (NR3C2) on pharmacological effect of MRAs in patients with STEMI through measurement of biochemical serum markers such as serum aldosterone, oxidative stress markers and cardiac remodeling markers.

Secondary Outcome Measures

Name	Time	Method
Gene Interaction	3 months	To investigate the potential interaction between these target gene polymorphisms and the overall patients' clinical outcome in response to treatment with Mineralocorticoid receptor antagonists (MRAs).
Gene incidence	3 months	To detect the incidence of aldosterone synthase (CYP11B2) and mineralocorticoid receptor (NR3C2) gene polymorphisms in Egyptian patients with ST- segment elevation (STEMI).

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt