Sodium-glucose Co-transporter 2 Inhibitors Effects in Failing Heart Patients

NCT03977116 | Completed Phase 4

• 1 other identifier: SecondUNI 05.06.2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM). These patients experience higher rate of ventricular arrhythmias (VA), that are a leading cause of cardiac arrest and mortality. However, these patients are treated by implantable cardioverter defibrillator (ICD) and cardiac resynchronization with defbrillator devices (CRTd) implant. In this setting, the catheter ablation (CA) treatment has been used to reduce the ventricular arrhythmias and the ICD/CRTds' interventions, and to prevent mortality events in these' patients. On other hand, still a higher percentage of patients result as non responders to an ablative approach with higher acute and long term mortality rate. Therefore, in the present study in a population of HF patients (DM vs. non DM patients) affected by VA, authors will investigate the effects of CA on mortality rate at 12 months of follow up. In addition, authors would demonstrate the ameliorative effects of new hypoglycemic drugs in addition to CA in patients with DM. However, after CA the patients with DM will be randomly assigned to SGLT2 therapy vs. placebo. Indeed, study hypothesis will be that, a) DM vs. non DM patients might have higher mortality rate after CA; b) patients with DM treated by CA plus SLGT2 therapy vs. patients with DM treated by CA plus placebo might experience a lower rate of mortality at 1 year of follow-up.

Conditions

Diabetes Mellitus; Heart Failure; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (3)

• all cause deaths

  after the intervention authors will evaluate all cause of deahs

  12 months

• cardiac deaths

  after the intervention authors will evaluate the cause of cardiac deahs

  12 months

• ventricular arrhythmias recurrence

  after the intervention authors will evaluate the cases of ventricular arrhythmias recurrences

  12 months

Secondary Outcomes (1)

• hospitalization for heart failure worsening

  12 months

Study Arms (2)

heart failure patients with diabetes treated by SGLT2 drugs

EXPERIMENTAL

Patients affected by heart failure and diabetes mellitus. These patients previous received an internal cardioverter defibrillator (ICD), and then a catheter ablation for ventricular arrhythmias (VA) therapy. After CA these patients received SLGT2 therapy.

Drug: SLGT2

heart failure patients with diabetes treated by placebo

PLACEBO COMPARATOR

Patients affected by heart failure and diabetes mellitus. These patients previous received an internal cardioverter defibrillator (ICD), and then a catheter ablation for ventricular arrhythmias (VA) therapy. After CA these patients received placebo therapy.

Drug: Placebo

Interventions

SLGT2 DRUG

These patients will receive SLGT2 therapy after catheter ablation.

heart failure patients with diabetes treated by SGLT2 drugs

Placebo DRUG

These patients will receive placebo therapy after catheter ablation.

heart failure patients with diabetes treated by placebo

Eligibility Criteria

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

You may qualify if:

• heart failure (HF) under optimal maximal drug therapy with NYHA functional II-III;
• HF with prior echocardiographic evidence of left ventricular systolic dysfunction (LVEF \<35 % or subjective assessment of LV dysfunction that is mild or worse);
• patients under furosemide 80 mg daily or less, or equivalent loop diuretic;
• patients with stable HF symptoms for at least 3 months prior to consent;
• patients on stable therapy for HF for at least 3 months prior to consent;
• patients without hospitalization for HF for at least 3 months prior to consent;
• Ischemic and non ischemic dilated cardiomiopathy diagnosis;
• patients with internal cardioverter defibrillator (ICD);
• patients with cardioverter resynchronization therapy and defibrillator (CRTd);
• patients with diagnosis of diabetes mellitus (DM);
• patients aged \>18 years and \<75 years

You may not qualify if:

• Patients without ICD;
• patients without previous event of ventricular arrhythmia (VA);
• patients without indication to receive catheter ablation (CA) for VA;
• patients with type 1 diabetes mellitus;
• severe hepatic disease, renal disease defined as chronic kidney disease stage 3b or worse (i.e. glomerular filtration rate \<45 ml/min);
• systolic blood pressure \<95 mmHg at screening visit;
• screening HbA1c \<6.0 %;
• patients unable to walk or to perform cardio pulmonary exercise testing or six minute walking test;
• malignancy (receiving active treatment) or other life threatening diseases;
• pregnant or lactating women;
• patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days;
• patients who were unable to give informed consent;

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)