SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.

University of Campania Luigi Vanvitelli

Status: Completed

Conditions: Diabetes Mellitus Type 2; SGLT2i; Heart Failure; ICD

Treatments: Device: internal cardioverter defibrillator implant (ICD); Procedure: percutaneous catheter ablation

Study type: Observational

Funder types: Other

Identifiers

NCT03366181

10.12.2017.2

Details and patient eligibility

About

Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated whether sodium glucose transporte-2 inhibitors (SGLT2i) could modulate serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide (BNP), C reactive protein (CRP), the heart rate (HR) and serum catecholamines in patients with type 2 diabetes mellitus (T2DM), and be used as predictors for the occurrence of malignant ventricular arrhythmias (VTAs) in patients who had received an Implantable Cardioverter Defibrillator (ICD) for primary prevention. In these T2DM patients with ICD we investigated the functionality of devices, the appropriate and inappropriate shocks, and the hospitalizations for heart failure and the cardiac deaths.

Enrollment: 500 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stable heart failure; indication for a ICD and/or a CRT-d system; NYHA Class II-III; left ventricle ejection fraction <35%; patients receiving optimal medical therapy without controindications to receive SGLT2i; diagnosis of T2DM.

Exclusion criteria

• NYHA Class I, and IV; co-morbidities which may limit life to <6 months; history of cardiac surgery or intervention within the preceding 90 days; history of moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for COPD flare-up; pregnancy; history of primary pulmonary hypertension.

Trial design

500 participants in 2 patient groups

Heart failure patients with T2DM and treated with ICD under SGLT2i therapy.

Description:

These patients with T2DM and stable heart failure were previously treated with ICD, and received a SGLT2i therapy. These patients were named SGLT2i-users.

Heart failure patients with T2DM and treated with ICD and without SGLT2i therapy.

Description:

Heart failure patients with T2DM and treated with ICD that did not receive the SGLT2i therapy. These patients were named Non-SGLT2i users.