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

Completed

• Conditions: Diabetes; Heart Failure
• Interventions: Drug: Antidiabetic

• Registration Number: NCT04375943
• Lead Sponsor: Federico II University

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.

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 Timeline

• Study Start: 2018-04-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-09-01
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-01
• Last Update Submitted: 2020-05-01
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetic HF-pEF patients	Antidiabetic	It is composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (\>45%).
diabetic HF-rEF patients	Antidiabetic	It is composed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Naples, Italy