DiabetesNCT04375943
Clinical and Echocardiographic Management of Patients With Heart Failure and Diabetes: SCODIAC Follow up Study
An observational study of Diabetes and Heart Failure, run by Federico II University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Diabetes, Heart Failure
- What is being tested?
- Antidiabetic
- How many people
- 406 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- cardiac surgery performed during the last year
- age less than 65 years
- significant valvulopathies
- malignant neoplasms
- advanced chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Diabetes, Heart Failure
- Being tested
- Antidiabetic
- Keywords
- diabetes, heart failure, ejection fraction
- Medical subject headings
- Diabetes Mellitus, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidiabeticDrug
Also called SGLT2 inhibitors, gliflozins, echocardiography.
Verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy
| Study group | Role | What they receive |
|---|---|---|
| diabetic HF-pEF patients | It is composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (>45%). Receives: Drug: Antidiabetic | |
| diabetic HF-rEF patients | It is composed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%). Receives: Drug: Antidiabetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol, LDL, HDL Triglycerides, Creatinine
mg/dl
Measured: 12 months
B-type natriuretic peptide (BNP)
pmol/m
Measured: 12 months
HbA1c
mmol/L
Measured: 12 months
Ejection Fraction
Measured: 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
Measured: 12 months
E velocity, A velocity,E' velocity
m/sec
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Apr 2018
- Primary completion1 Apr 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliviero Ugo, Federico II University
- Investigators
- Ugo Oliviero, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375943
- Sponsor's protocol ID
- FedericoIIArcaAmd
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Echocardiographic Management of Patients With Chronic Heart Failure and Type 2 Diabetes Mellitus: the SCODIAC Follow up Study
- ClinicalTrials.gov ID
- NCT04375943
- Acronym / sponsor ID
- FedericoIIArcaAmd
- Conditions
- Diabetes, Heart Failure
- Keywords
- diabetes, heart failure, ejection fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic HF-pEF patients | – | Drug: AntidiabeticIt is composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (>45%). |
| diabetic HF-rEF patients | – | Drug: AntidiabeticIt is composed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%). |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- cardiac surgery performed during the last year
- age less than 65 years
- significant valvulopathies
- malignant neoplasms
- advanced chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntidiabeticAlso: SGLT2 inhibitors, gliflozins, echocardiography.Verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy | Drug | diabetic HF-pEF patients, diabetic HF-rEF patients |
Primary outcome
Total Cholesterol, LDL, HDL Triglycerides, Creatinine
Time frame: 12 months
mg/dl
B-type natriuretic peptide (BNP)
Time frame: 12 months
pmol/m
HbA1c
Time frame: 12 months
mmol/L
Ejection Fraction
Time frame: 12 months
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
E velocity, A velocity,E' velocity
Time frame: 12 months
m/sec
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ugo Oliviero principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Heart Failure, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol, LDL, HDL Triglycerides, Creatinine (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.