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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04375943

Enrollment

406

Registered

2020-05-06

Start date

2018-04-01

Completion date

2019-09-01

Last updated

2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Heart Failure

Keywords

diabetes, heart failure, ejection fraction

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.

Interventions

DRUGAntidiabetic

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

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

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

Exclusion criteria

* cardiac surgery performed during the last year * age less than 65 years * significant valvulopathies * malignant neoplasms * advanced chronic kidney disease

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026