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

May 16, 2023 updated by: Isel Alansary, Ain Shams University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Recruiting
        • Ain shams university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Myocardial Infarction patients taking Aldosterone antagonist

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic polymorphism
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene Interaction
Time Frame: 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).
3 months
Gene incidence
Time Frame: 3 months
To detect the incidence of aldosterone synthase (CYP11B2) and mineralocorticoid receptor (NR3C2) gene polymorphisms in Egyptian patients with ST- segment elevation (STEMI).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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