Effects of empagliflozin on cardiac remodeling and myocardial sympathetic nervous system in diabetic patients affected by chronic heart failure

Phase 1

• Conditions: diabetes mellitus and heart failure; MedDRA version: 20.0Level: LLTClassification code 10011949Term: Decompensation cardiacSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002202-43-IT
• Lead Sponsor: AOU FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Age =18 years;
• Post-menopausal women, or no-pregnancy state (documented by pregnancy test);
• LVEF = 40% in at least two consecutive transthoracic echocardiographic evaluations;
• Stable clinical conditions (NYHA class II-III);
• Diagnosis of HF since at least 6 months;
• Stable optimal pharmacological HF therapy since at least 6 weeks;
• Type 2 DM with an indication to treatment with empagliflozin;
• Estimated glomerular filtration rate (eGFR) =30 ml/min/1.73m2 according to the
Modification of Diet in Renal Disease (MDRD) criteria;
• Capability to understand the study procedures and sign the informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Age =75 years;
• Type 1 DM;
• Suspected or known liver disease, defined by serum levels of alanine aminotransferase,
aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal;
• Planned cardiac surgery (including heart transplantation) or percutaneous coronary
intervention within 3 months;
• Acute coronary syndrome, stroke, or transient ischemic attack within 2 months before the
inclusion in the study;
• Estimated glomerular filtration (eGFR) <30 ml/min/1.73m2 according to the Modification of
Diet in Renal Disease (MDRD) criteria;
• Bariatric surgery within the past two years and other gastrointestinal surgeries that induce
chronic malabsorption;
• Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;
• Medical history of cancer and/or treatment for cancer within the last 5 years;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of empagliflozin on LV remodeling and function<br>To assess the effects of empagliflozin on biomarkers of HF hemodynamic status, i.e. natriuretic peptides levels, that are associated to prognosis in HF patients;Secondary Objective: To assess the effects of empagliflozin on myocardial sympathetic nervous system activity trough the assessment of catecholamine behaviors at the synaptic level evaluated by myocardial scintigraphy with I123-metaiodo-benzylguanidine (I123-MIBG);Primary end point(s): To assess the effect of empagliflozin on LV remodeling and function<br>To assess the effects of empagliflozin on biomarkers of HF hemodynamic status, i.e. natriuretic peptides levels, that are associated to prognosis in HF patients;Timepoint(s) of evaluation of this end point: 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess the effects of empagliflozin on myocardial sympathetic nervous system activity trough the assessment of catecholamine behaviors at the synaptic level evaluated by myocardial scintigraphy with I123-metaiodo-benzylguanidine (I123-MIBG);Timepoint(s) of evaluation of this end point: 24 Months