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

NCT06137430 | Unknown FDA Drug

• 1 other identifier: Effect of SGLT2 inhibitiors
• Study Type: observational
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

SGLT2 Inhibitiors Remodeling Effect; Chronic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diabetic patients with chronic heart failure

Drug: Sodium-glucose cotransporter 2 inhibitor

Non_diabetic patients with chronic heart failure

Drug: Sodium-glucose cotransporter 2 inhibitor

Interventions

Sodium-glucose cotransporter 2 inhibitor DRUG

Sodium glucose cotransporter 2 inhibitiors

Diabetic patients with chronic heart failure; Non_diabetic patients with chronic heart failure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diabetic and non-diabetic with chronic heart failure patients

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

Ahmad Abd eltwab Abd elzaher, GP

CONTACT

01001806037; ahmedabdeltwab777@gmail.com

Salwa Roshdy Demitry, Professor

CONTACT

01223971267; Salwademitry@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahmad Abd eltwab Abd elzaher

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11