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

NCT04375943 | Completed

• 1 other identifier: FedericoIIArcaAmd
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Heart Failure

Keywords

diabetes; heart failure; ejection fraction

Outcome Measures

Primary Outcomes (6)

• Total Cholesterol, LDL, HDL Triglycerides, Creatinine

  mg/dl

  12 months

• B-type natriuretic peptide (BNP)

  pmol/m

  12 months

• HbA1c

  mmol/L

  12 months

• 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)

  ml/m2

  12 months

• E velocity, A velocity,E' velocity

  m/sec

  12 months

Study Arms (2)

diabetic HF-pEF patients

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

Drug: Antidiabetic

diabetic HF-rEF patients

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

Drug: Antidiabetic

Interventions

Antidiabetic DRUG

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

Also known as: SGLT2 inhibitors, gliflozins, echocardiography.

diabetic HF-pEF patients; diabetic HF-rEF patients

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus; Heart Failure

Interventions

Hypoglycemic Agents; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action

Study Officials

• Ugo Oliviero

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 6, 2020
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

IT (1)