SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.

University of Campania Luigi Vanvitelli500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Heart Failure ICD Diabetes Mellitus Type 2 SGLT2i

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

cardiac deaths

authors will report cardiac deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry.

Time frame: 12 months

Heart failure hospitalization

authors will report heart failure hospitalization by hospital discarge schedules, visits, telephonic interviews.

Time frame: 12 months

ICDs' intervention

authors will report ICDs' intervention by hospital discarge schedules, visits, telephonic interviews, and telemetric devices interrogations.

Time frame: 12 months

Secondary Outcomes

arrhythmic burden

authors will report arrhythmic burden by hospital discarge schedules, visits, telephonic interviews, egg hollering, and telemetric devices interrogations.

Time frame: 12 months

SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes