Effect of Genetic Polymorphisms on Response to Beta Blocker Therapy in Egyptian Patients

Beta-blockers represent a cornerstone for the treatment of coronary artery disease (CAD). Their protective effect is based on the negative inotropic and chronotropic features, which have been tested in a large number of randomized controlled trials, both in patients with myocardial infarction (MI) and in those with stable angina, demonstrating a reduction of adverse cardiovascular events, a relief of symptoms and a reduction of myocardial ischemia

However, considerable interpatient variability in response to β-blockers has been reported which indicates that a considerable proportion of β-blocker-treated patients do not achieve the warranted cardio protection with β- blockers. This highlights the importance of identifying biomarkers associated with variability in response to β-blockers to improve the current approach for β- blocker selection, which seems to be suboptimal.

This study aims to study the effect of polymorphism in adrenergic beta receptors on beta-blocker response in Egyptian patients.

Study Overview

• Status: Completed
• Conditions: Hypertension; Acute Coronary Syndrome

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • Al Qahirah
    • Cairo, Al Qahirah, Egypt, 12234
      • Ain Shams University Hospitals.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Beta-Blocker naive Egyptian patient with acute coronary syndrome.

Description

Inclusion Criteria:

1. Beta-blockers naïve patients
2. Patients been on beta-blocker therapy for at least 4 weeks.
3. Age (18-75) Years old.

Exclusion Criteria:

1. Non-Egyptians.
2. Kidney failure of any stage.
3. Liver failure of any stage.
4. Malignancy.
5. Pregnancy.
6. HR < 55 beats/min (in the absence of b-blocker therapy).
7. Presence of a cardiac pacemaker.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
beta blocker navie patients with acute coronary syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adrenergic receptors genes and blood pressure response to beta-blocker	Investigate the association of the adrenergic receptor polymorphisms with reduction in blood pressure (expressed in units of millimeters of mercury "mmHg" ) in the Egyptian patients with acute coronary syndrome on beta blocker therapy.	Three months
Adrenergic receptors genes and heart rate response to beta-blocker	Investigate the association of the adrenergic receptor polymorphisms with reduction in heart rate (expressed as beats per minute "BPM" ) in the Egyptian patients with acute coronary syndrome on beta blocker therapy.	Three months

Collaborators and Investigators

• Sponsor: Mohamed Saleh Fayed
• Investigators: Study Chair: Nagwa A Sabry, PhD, Ains Shams university; Study Director: Mohamed A Saleh, PhD, Ain Shams University; Study Director: Amal A EL-Kholy, PhD, Ain Shams University; Principal Investigator: Mohamed S Fayed, Bsc, Ains Shams university

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: PHCL135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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