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OpenTrials
Completed

NCT Number: NCT03366181

SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases ICD Metabolic Diseases Nutritional and Metabolic Diseases SGLT2i

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Raffaele Marfella

Naples, Italy, 80128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. cardiac deaths

    Time frame: 12 months

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

  2. Heart failure hospitalization

    Time frame: 12 months

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

  3. ICDs' intervention

    Time frame: 12 months

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

Secondary outcomes

  1. arrhythmic burden

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2017
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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