SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.

NCT03366181 | Completed

• 1 other identifier: 10.12.2017.2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; ICD; Diabetes Mellitus Type 2; SGLT2i

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• arrhythmic burden

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, Italy, 80128, Italy

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 8, 2017
• Study Start: November 1, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 26, 2017
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

IT (1)