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

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT04375943

Collaborator

(none)

406

Enrollment

Location

Actual Duration (Months)

23.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Heart Failure	Drug: Antidiabetic

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

406 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

diabetic HF-pEF patients

It is composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (>45%).

Drug: Antidiabetic

Verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy

Other Names:

SGLT2 inhibitors, gliflozins, echocardiography.

diabetic HF-rEF patients

It is composed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%).

Drug: Antidiabetic

Verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy

Other Names:

SGLT2 inhibitors, gliflozins, echocardiography.

Outcome Measures

Primary Outcome Measures

Total Cholesterol, LDL, HDL Triglycerides, Creatinine [12 months]
mg/dl
B-type natriuretic peptide (BNP) [12 months]
pmol/m
HbA1c [12 months]
mmol/L
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) [12 months]
ml/m2
E velocity, A velocity,E' velocity [12 months]
m/sec

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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