The Impact of Genetic Polymorphism on the Echocardiographic Parameters and Cardiac Fibrosis Markers in Response to Empagliflozin Treatment Among Patients With Heart Failure

NCT06503601 | Active Not Recruiting

• 1 other identifier: rec#264
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

It is important to assess the implications of genetic variants of the TGF-β1 gene in patients with HFrEF and the association of this polymorphism with treatment response to SGLT2I. Therefore, by correlating the pharmacogenetics hand in hand with the mechanistic markers involved in the pathogenesis of HF, this can aid in the development of individualized, therapeutic strategies and improve the patient's drug response.

Conditions

Heart Failure

Keywords

Heart Failure; genetic polymorphism; cardiac fibrosis markers; empagliflozin; echocardiographic parameters

Outcome Measures

Primary Outcomes (1)

• Genetic polymorphism and echocardiographic parameters

  To detect association between a TGFβ1 gene polymorphism variants and echocardiographic outcome of patients with HFrEF in response to empagliflozin.

  3-6 months

Secondary Outcomes (1)

• Cardiac fibrosis biochemical markers

  3-6 months

Study Arms (2)

Responders to empagliflozin

Heart failure patients who showed response to empagliflozin

Non responders to empagliflozin

Heart failure patients who showed no response to empagliflozin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Heart failure patients treated with empagliflozin

You may qualify if:

• Heart failure patients NYHA class II to IV.
• Treatment with beta blockers, MRAs, ACEIs in addition to empagliflozin.
• Age of 18 years to 80 years.
• Written informed consent of the subject to participate in the study.

You may not qualify if:

• Contraindication to empagliflozin: pregnancy, hypersensitivity, and severe renal impairment.
• CABG or valve surgery within 3 months.
• Mild-to-severe valvular stenosis or severe (grade III/IV) valvular regurgitation
• Pregnant or nursing women.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 11315, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: July 30, 2023
• Primary Completion: July 30, 2025
• Study Completion: October 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

EG (1)