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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05873400

Collaborator

(none)

102

Enrollment

Location

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction

Study Design

Study Type:

Observational

Anticipated Enrollment :

102 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
1 Myocardial Infarction patients who responded to aldosterone antagonist and didn't develope heart failure
2 Myocardial Infarction patients who didn't respond to aldosterone antagonist and developed heart failure
3 Control group who didn't receive aldosterone antagonist

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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%).