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

NCT05873400 | Unknown

• 1 other identifier: 95
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Aldosterone Antagonist; Myocardial Infarction; Cardiac remodeling; Gene polymorphism; Remodeling Marker; Stress Marker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gene Interaction

  3 months

• Gene incidence

  3 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Myocardial Infarction patients taking Aldosterone antagonist

You may qualify if:

• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Isel Al-ansary, Bachelor Degree

CONTACT

01098173054; isele.alansary@gmail.com

Neven Sarhan, PhD

CONTACT

01021944422; sarhanneven@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Researcher

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)