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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diabetes
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 406

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Federico II University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 406 patient with HF and T2DM, referred to ARCA Cardiologists from 17 healthcare districts in Campania and to AMD Physicians from 8 Antidiabetic Centers and followed for at least one year between 2018 and 2019, were enrolled.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejection Fraction		12 months
Total Cholesterol, LDL, HDL Triglycerides, Creatinine	mg/dl	12 months
B-type natriuretic peptide (BNP)	pmol/m	12 months
HbA1c	mmol/L	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

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Ugo Oliviero, Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: diabetes; heart failure; ejection fraction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Failure; Diabetes Mellitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: FedericoIIArcaAmd

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No