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

Study identification

• EU PAS number:
  EUPAS27636
• Study ID:
  27637
• Official title and acronym:
  Effects of empagliflozin on cardiac remodeling and myocardial sympathetic nervous system in diabetic patients affected by chronic heart failure
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Background. Heart failure (HF) patients often exhibit several comorbidities that contribute to affect prognosis. In particular, type 2 diabetes mellitus (DM) is common in HF with prevalence from 10 to 30% and adversely influences long-term morbidity and mortality of symptomatic and asymptomatic HF patients. The results of a recent study on the effects of the anti-diabetic drug empagliflozin, reported unattended and substantial favorable effects on cardiovascular outcomes, and in particular a striking reduction of HF hospitalization, that was consistently demonstrated in patients with and without HF at baseline. The mechanisms behind these effects are unknown and many potential contributors have been advocated, including effects on plasma volume, arterial stiffness, sympathetic nervous system modulation and cardiac remodeling.Objectives. Aim of the present study is to investigate the mechanisms underlying the beneficial effects of empagliflozin on cardiovascular outcomes in diabetic patients affected by chronic HF with reduced left ventricular ejection fraction. In particular, the primary endpoint is to assess the effect of empagliflozin on left ventricular remodeling and function and on biomarkers of HF hemodynamic status. Secondary endpoint is to assess the effects of empagliflozin on myocardial sympathetic nervous system activity.Methods. Prospective cohort study. Patients will receive empagliflozin according to diabetologists’ prescription. Endpoints will be evaluated by in each study procedure by two investigators blinded to personal patients’ data and treatment allocation. On the first study day patients will undergo clinical examination, echocardiography and I123MIBG Imaging to assess myocardial adrenergic status. Then patients will start the prescribed treatment and after 6-9 months of follow-up will repeat the baseline study procedures to assess the effects of empagliflozin on study outcomes.
• Study status:
  Planned

Research institutions and networks

Institutions

University of Naples Federico II

Study timelines

Date when funding contract was signed

Planned:03/12/2018

Study start date

Planned:03/06/2019

Date of final study report

Planned:03/06/2021

Sources of funding

Other

More details on funding

Federico II University of Naples

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable