SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.

SGLT2i As Anti Arrhythmic Therapies and Sudden Cardiac Death in Implantable Cardioverter Defibrillators (ICDs) Recipients

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 Overview

• Status: Completed
• Conditions: Heart Failure; Diabetes Mellitus Type 2; ICD; SGLT2i
• Intervention / Treatment: Device: internal cardioverter defibrillator implant (ICD); Procedure: percutaneous catheter ablation

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80128
    • Raffaele Marfella

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

heart failure patients with reduced LVEF (LVEF <35%) and affected by T2DM, previously treated with ICD and indication to receive SGLT2i therapy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arrhythmic burden	authors will report arrhythmic burden by hospital discarge schedules, visits, telephonic interviews, egg hollering, and telemetric devices interrogations.	12 months

Collaborators and Investigators

• Sponsor: University of Campania Luigi Vanvitelli

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): November 26, 2017

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Heart Arrest; Death, Sudden; Diabetes Mellitus, Type 2; Death, Sudden, Cardiac; Death
• Other Study ID Numbers: 10.12.2017.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No