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Completed

NCT Number: NCT04375943

Clinical and Echocardiographic Management of Patients With Heart Failure and Diabetes: 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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federico II University

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antidiabetic

Drug

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

Other names: SGLT2 inhibitors, gliflozins, echocardiography.

Primary outcomes

  1. Total Cholesterol, LDL, HDL Triglycerides, Creatinine

    Time frame: 12 months

    mg/dl

  2. B-type natriuretic peptide (BNP)

    Time frame: 12 months

    pmol/m

  3. HbA1c

    Time frame: 12 months

    mmol/L

  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)

    Time frame: 12 months

    ml/m2

  6. E velocity, A velocity,E' velocity

    Time frame: 12 months

    m/sec

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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