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

NCT ID: NCT05873400

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-04-01

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Myocardial Infarction patients who responded to aldosterone antagonist and didn't develope heart failure

No interventions assigned to this group

2

Myocardial Infarction patients who didn't respond to aldosterone antagonist and developed heart failure

No interventions assigned to this group

3

Control group who didn't receive aldosterone antagonist

No interventions assigned to this group

Eligibility Criteria

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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%).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Isel Alansary

Academic Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Isel Al-ansary, Bachelor Degree

Role: CONTACT

01098173054

Neven Sarhan, PhD

Role: CONTACT

01021944422

Facility Contacts

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Dr. Ebtehal El Demerdash Zaki, Professor

Role: primary

01158600303

Other Identifiers

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95

Identifier Type: -

Identifier Source: org_study_id

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