Clinical trial

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

Name
Effect of SGLT2 inhibitiors
Description
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
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-12-01
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
Sodium-glucose cotransporter 2 inhibitor
Sodium glucose cotransporter 2 inhibitiors
Arms:
Diabetic patients with chronic heart failure, Non_diabetic patients with chronic heart failure
Size
98
Primary endpoint
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
Baseline
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 98, 'type': 'ESTIMATED'}}
Updated at
2023-11-18

1 organization

1 product

2 indications

Organization
Assiut University