Effect of Sodium Glucose Cotransporter 2 Inhibitiors on Left Ventricular Remodeling Among Diabetic and Non Diabetic Patients With Chronic Heart Failure

To evaluate the efficacy of SGLT2 inhibitors on left ventricular global longitudinal strain and diastology parameters among diabetic and non-diabetic patients with chronic heart failure

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Heart Disease; SGLT2 Inhibitiors Remodeling Effect
• Intervention / Treatment: Drug: Sodium-glucose cotransporter 2 inhibitor

Detailed Description

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have an established place in the therapy of heart failure (HF), as they have been shown to significantly reduce all-cause mortality, cardiovascular mortality, and hospitalizations in HFrEF patients, regardless of the presence of diabetes mellitus.

The growing evidence of the effect of SGLT2i on cardiac remodeling through cellular, molecular, vascular, interstitial, and electrical effects justifies its role as fundamental HF therapy.

SGLT2 inhibition in heart failure promotes reverse cardiac remodeling and is associated with better clinical outcomes.

Adverse myocardial remodeling affecting the left ventricle is a key factor in HF progression, and current well-established HF phenotypes are based on LVEF. However, other relevant players, such as the left atrium, have received less attention. Indeed, the left atrium plays a critical role in cardiac function, particularly in left ventricular (LV) filling during diastole. Additionally, atrial dysfunction can directly lead to pulmonary congestion. Left atrial (LA) remodeling occurs in HF irrespective of the degree of LV systolic dysfunction and can be observed in the presence of preserved or reduced LVEF. SGLT2 inhibition has been associated with reduced left ventricular (LV) and left atrial volumes in HF; however, its relationship with contemporary echocardiographic parameters of global LV systolic function, including global longitudinal strain and myocardial work, has not been thoroughly investigated.

Measuring the effect of SGLT2i therapy on left ventricular systolic function (LV) has previously been assessed by changes in heart size volume and ejection fraction.

In current clinical practice, the assessment of LV systolic function is still mainly based on the measurement of LV ejection fraction (LVEF), which remains the gold standard despite some notable limitations.

In the last decade, LV global longitudinal strain (GLS) has emerged as a more accurate predictor of poor outcomes, revealing subtle abnormalities and preclinical LV systolic dysfunction.

• Study Type: Observational
• Enrollment (Estimated): 98

Contacts and Locations

• Study Contact: Name: Ahmad Abd eltwab Abd elzaher, GP; Phone Number: 01001806037 01001806037; Email: ahmedabdeltwab777@gmail.com
• Study Contact Backup: Name: Salwa Roshdy Demitry, Professor; Phone Number: 01223971267 01223971267; Email: Salwademitry@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

diabetic and non-diabetic with chronic heart failure patients

Description

Inclusion Criteria:

- The study will enroll outpatients with HF on optimized medical therapy defined by the guidelines of the European Society of Cardiology (ESC) that were used when the study was initiated.

Age ranges from 18 to 75 years

Exclusion Criteria:

• age <18 and > 75 years. 2. If there is any contraindication in using SGLT2 inhibitors, patients that had symptomatic hypotension (systolic blood pressure < 95 mmHg, impaired renal function (eGFR <30ml/min/1.73m2 calculated by the CKD-EPI formula), Potassium serum levels > 5.2 mmol/L and Liver dysfunction (defined as hepatic parameters such as ALT, AST and/or ALP elevated ≥3 times above the upper 99th reference percentile.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic patients with chronic heart failure	Drug: Sodium-glucose cotransporter 2 inhibitor; Sodium glucose cotransporter 2 inhibitiors
Non_diabetic patients with chronic heart failure	Drug: Sodium-glucose cotransporter 2 inhibitor; Sodium glucose cotransporter 2 inhibitiors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular global longitudinal strain and diastology parameters, including (left atrial volume indexed) LAVI in chronic heart failure patients on SGLT2 inhibitors, comparing diabetic and non-diabetic patients	Effect of SGLT2 inhibitiors on left ventricular remodeling among diabetic and non diabetic patients with chronic heart failure	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Failure; Heart Diseases; Ventricular Remodeling; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: Effect of SGLT2 inhibitiors

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes