Clinical and Echocardiographic Management of Patients With Heart Failure and Diabetes: SCODIAC Follow up Study

Study Overview
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Brief Summary
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The study has been carried out to determine diagnostic and therapeutic pathways in a group of HF diabetic patients and to verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy.

Detailed Description
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406 patients affected with heart failure and Type 2 Diabetes Mellitus, referred to Cardiologists and Diabetologists of pertaining healthcare districts in Campania, and followed for at least one year between 2018 and 2019, were enrolled in this retrospective study and divided in Group A, composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (>45%) and Group B, formed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%). All patients had performed periodic clinical evaluations and an echocardiographic exam every 12 months. Anthropometric parameters, HF etiology, co-morbidities, complications and ongoing therapies were collected.

Official Title
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Clinical and Echocardiographic Management of Patients With Chronic Heart Failure and Type 2 Diabetes Mellitus: the SCODIAC Follow up Study

Conditions
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Diabetes, Heart Failure

Intervention / Treatment
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* Drug: Antidiabetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age at least 65 years presence of chronic HF, defined as a stable clinical syndrome with typical symptoms and signs and echocardiographic evidence of cardiac involvement New York Heart Association (NYHA) class II-III diagnosis of T2DM from at least 2 years Exclusion Criteria: cardiac surgery performed during the last year age less than 65 years significant valvulopathies malignant neoplasms advanced chronic kidney disease

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetic HF-pEF patients<br>It is composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (>45%). | Drug: Antidiabetic<br>* Verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy<br>* Other names: SGLT2 inhibitors, gliflozins, echocardiography.;|
| diabetic HF-rEF patients<br>It is composed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%). | Drug: Antidiabetic<br>* Verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy<br>* Other names: SGLT2 inhibitors, gliflozins, echocardiography.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol, LDL, HDL Triglycerides, Creatinine | mg/dl | 12 months | 
| B-type natriuretic peptide (BNP) | pmol/m | 12 months | 
| HbA1c | mmol/L | 12 months | 
| Ejection Fraction |  | 12 months | 
| Left Ventricular End-Diastolic Volume Index (LV-EDVi), Left Ventricular End-Systolic Volume Index (LV-ESVi), Left Atrial Volume Index (LAVi) | ml/m2 | 12 months | 
| E velocity, A velocity,E' velocity | m/sec | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, heart failure, ejection fraction