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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873400
• Other study ID #: 95
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: Isel Al-ansary, Bachelor Degree
• Phone: 01098173054
• Email: isele.alansary[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: April 1, 2024
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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%).

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic polymorphism	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.	3 months
Secondary	Gene Interaction	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).	3 months
Secondary	Gene incidence	To detect the incidence of aldosterone synthase (CYP11B2) and mineralocorticoid receptor (NR3C2) gene polymorphisms in Egyptian patients with ST- segment elevation (STEMI).	3 months