Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000795291
Ethics application status
Approved
Date submitted
29/03/2018
Date registered
10/05/2018
Date last updated
22/01/2019
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Sodium Glucose Co-Transpoter-2 (SGLT-2) in diabetics with heart failure
Scientific title
Effects of Sodium Glucose Co-Transporter-2 (SGLT-2) on self-reported symptoms and serum biomarkers in patients with diabetes and heart failure.
Secondary ID [1] 294469 0
nil known
Universal Trial Number (UTN)
U1111-1211-5199
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 307230 0
Type 2 Diabetes 307231 0
Condition category
Condition code
Cardiovascular 306343 306343 0 0
Other cardiovascular diseases
Metabolic and Endocrine 306344 306344 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to test the hypothesis that treatment with sodium-glucose co-transporter 2(SGLT-2) inhibitors will decrease the risk, progression and severity of heart failure and also if there is any benefit in the quality of life in these patients following the addition of a SGLT-2 inhibitor to standard medical care.

Exposure:
The patients will be recruited from the Endocrinology Clinics at Eastern Health - Box Hill Hospital and Maroondah Hospital. All patients meeting the inclusion criteria will have medical history and physical examination performed, baseline blood tests and functional status as assessed by the Minnesota Living with Heart failure questionnaire. SGLT-2 inhibitors (dapaglifozin or empaglifozin) will be started in the course of normal clinical practice and according to exisiting guidelines. The SGLT-2 inhibitor will be added to additional therapy or substituted for additional therapy at the discretion of the treating physician.
They will be followed up over the period of 6 months and the blood tests will be repeated. The quality of life will be assessed again using the Minnesota Living with Heart failure questionnaire.

The blood tests include: hsCRP, troponin, BNP, HbA1c
Intervention code [1] 300762 0
Not applicable
Comparator / control treatment
No Control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305355 0
Change in the cardiac function as a composite outcome of changes in serum biomarkers - troponin, high sensitivity CRP(hsCRP) and brain natriuretic peptide(BNP) levels
Timepoint [1] 305355 0
6 months from time of initiation of SGLT-2 inhibitor.
Secondary outcome [1] 344937 0
Change in self reported symptoms as assessed by changes in the scores for Minnesota Living with Heart Failure Questionnaire.
Timepoint [1] 344937 0
6 months from time of initiation of SGLT-2 inhibitor.
Secondary outcome [2] 344938 0
Change in functional class as assessed by changes in NYHA functional class
Timepoint [2] 344938 0
6 months from time of initiation of SGLT-2 inhibitor.
Secondary outcome [3] 346496 0
Change in serum troponin
Timepoint [3] 346496 0
6 months from time of initiation of SGLT-2 inhibitor.
Secondary outcome [4] 346497 0
Change in hsCRP measured by serum assay.
Timepoint [4] 346497 0
6 months from time of initiation of SGLT-2 inhibitor.
Secondary outcome [5] 346498 0
Change in BNP measured by serum assay
Timepoint [5] 346498 0
6 months from time of initiation of SGLT-2 inhibitor.

Eligibility
Key inclusion criteria
- Patients aged between 18 and 85 with established heart failure (New York Heart Association Class II, III, IV) AND
- Receiving treatment for type 2 diabetes mellitus with metformin, a sulphonylurea, a dual oral therapy, a combination of insulin and oral agents or insulin alone in cases where oral antidiabetic medications are contraindicated.
- The HbA1c measurements of participants should be greater than 7.0% and obtained within the preceding 4 months.
- Endocrinology team have assessed and deemed the patient suitable to be commenced on SGLT-2 inhibitors as per current guidelines.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with type 1 diabetes mellitus, stage 3B, 4 and 5 chronic kidney disease (including patients on dialysis), galactose intolerance and a history of alcohol misuse, ketoacidosis or recurrent genitourinary infections.
- Patients already receiving treatment with a dipeptidyl peptidase 4 inhibitor, thiazolidinedione or a glucagon-like peptide-1 .

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The Minnesota Living with Heart Failure Questionnaire scores of participants at baseline and 6 months from the commencement of a SGLT-2 inhibitor would be analysed using the Wilcoxon test. Analysis of serum biomarker levels may be performed with a paired t-test given the small intended sample size for this study.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
15/05/2018
Actual
21/05/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
8/08/2018
Date of last data collection
Anticipated
31/05/2019
Actual
8/08/2018
Sample size
Target
40
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10523 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 10524 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 22238 0
3128 - Box Hill
Recruitment postcode(s) [2] 22239 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 299091 0
Hospital
Name [1] 299091 0
Endocrinology Department, Box Hill Hospital - Eastern Health
Country [1] 299091 0
Australia
Primary sponsor type
Hospital
Name
Endcrinology Department, Box Hill Hospital - Eastern Health
Address
5 Arnold Street, Box Hill. VIC 3128
Country
Australia
Secondary sponsor category [1] 298344 0
None
Name [1] 298344 0
Address [1] 298344 0
Country [1] 298344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300028 0
Human Research Ethics Committee - Scientific and Ethical Review. Eastern Health
Ethics committee address [1] 300028 0
Level 2, 5 Arnold Street, Box Hill. VIC 3128
Ethics committee country [1] 300028 0
Australia
Date submitted for ethics approval [1] 300028 0
13/01/2018
Approval date [1] 300028 0
13/02/2018
Ethics approval number [1] 300028 0
LR06-2018

Summary
Brief summary
Background: Patients with type 2 diabetes mellitus area at a higher risk of developing heart failure and a significant number of patients with established heart failure are receiving treatment for type 2 diabetes mellitus. The EMPA-REG OUTCOME study concluded that the inclusion of empagliflozin in the treatment received by patients with a high risk for cardiovascular events reduced the rate of primary adverse cardiovascular outcomes and mortality.
Aim: The aim of this study is to test the hypothesis that treatment with sodium-glucose co-transporter 2(SGLT-2) inhibitors will decrease the risk, progression and severity of heart failure and also if there is any benefit in the quality of life in these patients following the addition of a SGLT-2 inhibitor as part of standard medical care.

Methods: Participants will be recruited from the diabetes clinics at Box Hill and Maroondah Hospitals. These patients will have been identified by their treating physicians as suitable for SGLT-2 inhibitors. The SGLT-2 inhibitors (dapaglifozin or ertuglifozin) will be started in the course of normal clinical practice and according to existing clinical guidelines. The SGLT-2 inhibitor will be added to additional therapy or substituted for additional therapy at the discretion of the treating physician. Baseline blood tests and a Living with Heart failure questionnaire will be completed by the patients. Treatment will be monitored and further changes to therapy, the addition of other agents or the discontinuation of other agents, including SGLT-2 inhibitors, will also be at the discretion of the treating physician. Audit information will be collected prospectively but no information will be collected that is not a normal part of clinical practice in patients with heart failure.

Recruitment of the participants will be by the registrars/consultants from the diabetes clinics after a thorough discussion about the safety of SGLT2 inhibitors and with full consent by the patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82310 0
Prof Chris Gilfillan
Address 82310 0
Department of Endocrinology- Eastern Health, Level 2, 5 Arnold Street. Box Hill VIC 3128
Country 82310 0
Australia
Phone 82310 0
+61 3 90926753
Fax 82310 0
Email 82310 0
chris.gilfillan@easternhealth.org.au
Contact person for public queries
Name 82311 0
Dr Shananthan Balachandran
Address 82311 0
Department of General Medicine - Eastern Health. 5 Arnold Street, Box Hill VIC 3128
Country 82311 0
Australia
Phone 82311 0
+61 3 9895 3128
Fax 82311 0
Email 82311 0
shananthan.balachandran@easternhealth.org.au
Contact person for scientific queries
Name 82312 0
Dr Harsh Thakkar
Address 82312 0
Department of General Medicine - Eastern Health. 5 Arnold Street, Box Hill VIC 3128
Country 82312 0
Australia
Phone 82312 0
+61 3 9895 3128
Fax 82312 0
Email 82312 0
harsh.thakkar@easternhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Adequate participants haven't been recruited hence data will not be stored.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.