CClinicalTrials.gg
CompletedNCT04375943Updated May 6, 2020

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

An observational study in Diabetes and Heart Failure, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-06.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
406
Ages
65 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes
  • Heart Failure

Keywords

  • diabetes
  • heart failure
  • ejection fraction
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 406 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • cardiac surgery performed during the last year
  • age less than 65 years
  • significant valvulopathies
  • malignant neoplasms
  • advanced chronic kidney disease
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
406 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugAntidiabetic

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

    Also known as: SGLT2 inhibitors, gliflozins, echocardiography.

06

What researchers measure

Primary outcomes

  1. Total Cholesterol, LDL, HDL Triglycerides, Creatinine

    mg/dl

    Time frame: 12 months

  2. B-type natriuretic peptide (BNP)

    pmol/m

    Time frame: 12 months

  3. HbA1c

    mmol/L

    Time frame: 12 months

  4. Ejection Fraction

    Time frame: 12 months

  5. Left Ventricular End-Diastolic Volume Index (LV-EDVi), Left Ventricular End-Systolic Volume Index (LV-ESVi), Left Atrial Volume Index (LAVi)

    ml/m2

    Time frame: 12 months

  6. E velocity, A velocity,E' velocity

    m/sec

    Time frame: 12 months

07

Study locations

1 site
  • Federico II University
    Naples, 80131, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04375943
Lead sponsor
Federico II University
Responsible party
Oliviero Ugo (Principal investigator, Federico II University) — Principal investigator
First posted
May 6, 2020
Start date
Apr 1, 2018
Primary completion
Apr 1, 2019
Completion
Sep 1, 2019
Last update
May 6, 2020

Study contacts

Ugo Oliviero
principal investigator · Federico II University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion