SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.

Completed

• Conditions: Heart Failure; ICD; Diabetes Mellitus Type 2; SGLT2i
• Interventions: Device: internal cardioverter defibrillator implant (ICD); Procedure: percutaneous catheter ablation

• Registration Number: NCT03366181
• Lead Sponsor: University of Campania Luigi Vanvitelli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-26
• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
heart failure patients	internal cardioverter defibrillator implant (ICD)	-
heart failure patients	percutaneous catheter ablation	-

Primary Outcome Measures

Name	Time	Method
cardiac deaths	12 months	authors will report cardiac deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry.
Heart failure hospitalization	12 months	authors will report heart failure hospitalization by hospital discarge schedules, visits, telephonic interviews.
ICDs' intervention	12 months	authors will report ICDs' intervention by hospital discarge schedules, visits, telephonic interviews, and telemetric devices interrogations.

Secondary Outcome Measures

Name	Time	Method
arrhythmic burden	12 months	authors will report arrhythmic burden by hospital discarge schedules, visits, telephonic interviews, egg hollering, and telemetric devices interrogations.

Trial Locations

Locations (1)

Raffaele Marfella; 🇮🇹 Naples, Italy