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

NCT ID: NCT04375943

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 406 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-09-01

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.

Conditions

Diabetes; Heart Failure

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

diabetic HF-pEF patients

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

Antidiabetic

Intervention Type: DRUG

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

diabetic HF-rEF patients

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

Antidiabetic

Intervention Type: DRUG

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

Interventions

Antidiabetic

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

Intervention Type: DRUG

Other Intervention Names

SGLT2 inhibitors, gliflozins, echocardiography.

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Oliviero Ugo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ugo Oliviero

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

Federico II University

Naples, , Italy

Countries

Italy

Other Identifiers

FedericoIIArcaAmd

Identifier Type: -

Identifier Source: org_study_id