None listed
Conditions
Brief summary
We are aiming to assess the effect of commencing empagliflozin (Jardiance), a medication used for blood glucose lowering on heart function and structure. This ultimately may lead to a better understanding of the effects of this class of medication on heart function.
Interventions
1. EXPOSURE
allocation: empagliflozin as per clinical indication
dose: 10 mg daily
mode of administration: oral tablet
duration: 6 months minimum and ongoing unless clinical indication to cease
2. INVESTIGATIONS
(i) height and weight which takes 2 minutes
(ii) blood test for HbA1c and BNP which takes 2 minutes
(iii) New York Heart Association Functional Classification questionnaire which takes 1 minutes
(iv) cardiac MRI which takes 90 minutes
3. DURATION OF FOLLOW-UP
6 months
all investigatio
1. EXPOSURE allocation: empagliflozin as per clinical indication dose: 10 mg daily mode of administration: oral tablet duration: 6 months minimum and ongoing unless clinical indication to cease 2. INVESTIGATIONS (i) height and weight which takes 2 minutes (ii) blood test for HbA1c and BNP which takes 2 minutes (iii) New York Heart Association Functional Classification questionnaire which takes 1 minutes (iv) cardiac MRI which takes 90 minutes 3. DURATION OF FOLLOW-UP 6 months all investigations are undertaken at baseline and at 6 months follow-up
Sponsors
Baker IDI Heart and Diabetes Institute
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Sex: all Age: 18 - 75 years Disease status and severity: type 2 diabetes with HbA1c > 7% (in accordance with PBS requirements) Informed consent: participant must be able to give personal informed consent Participation in the study: participant must be able to co-operate sufficiently to allow the proposed study to progress. Concomitant medications: no restriction is made in the use of concomitant medications, which will be left to the treating specialist
Exclusion criteria
Age: less than 18 years and greater than 75 years Disease status and severity: type 1 diabetes and type 2 diabetes with HbA1c less than 7% Pregnancy and breast feeding: females must not be pregnant or breast feeding or at risk of becoming pregnant (permanent or effective contraception required – hysterectomy, tubal ligation, IUD or OCP) Concomitant medications: No restriction in concomitant medications except the use of an SGLT2 inhibitor the control group. Contraindications to magnetic resonance imaging: metallic implants
Outcome results
None listed