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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375943
• Other study ID #: FedericoIIArcaAmd
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: May 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: September 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cholesterol, LDL, HDL Triglycerides, Creatinine	mg/dl	12 months
Primary	B-type natriuretic peptide (BNP)	pmol/m	12 months
Primary	HbA1c	mmol/L	12 months
Primary	Ejection Fraction		12 months
Primary	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
Primary	E velocity, A velocity,E' velocity	m/sec	12 months