A Phase 4 interventional study of Dapagliflozin and Placebo in Heart Failure and Diabetes, sponsored by University of Dundee. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-31.
Sponsored by University of Dundee · Phase 4, Interventional, and Treatment
Patients with diabetes are at increased risk of developing heart failure (HF) which can lead to increased shortness of breath, reduced ability to exercise and in some cases premature death as the heart becomes less efficient at pumping blood around the body. However the treatment options for such patients remain limited.
This study will test the safety and benefits of using a new class of drug, the SGLT2 Inhibitor (Dapagliflozin), in treating HF and diabetes.
Participants will have a Magnetic Resonance Imaging (MRI) scan of the heart, to measure the efficiency and the extent of thickening of the heart muscle before they start on treatment of dapagliflozin, or placebo for one year. They will also do exercise testing on an exercise bike (if capable) and a walking test plus fill in some questionnaires on how their heart failure affects their quality of life. Participants will then continue as normal with currently prescribed medication for their diabetes and heart failure. After a year the tests will be repeated to determine if patients receiving Dapagliflozin benefited more than those who weren't on the drug.
This study is funded by the European Foundation for the Study of Diabetes (EFSD)
Men and women with diabetes have a 2-5-fold increased risk of heart failure (HF). The prevalence and incidence of HF is increasing in diabetes and mortality rates remain alarmingly high. This highlights the need for novel therapies in diabetes that will reduce HF risk and /or delay disease progression.
Drug options are currently limited as some diabetic therapies such as thiazolidinediones are contra-indicated in HF. SGLT2 inhibitors, the newest class of anti-diabetic drugs, are an exciting new approach to diabetes management that may have additional beneficial effects in diabetes and HF. SGLT2 inhibitors may have beneficial effects on adverse left ventricular (LV) remodelling that occurs in patients with diabetes and heart failure by reducing the load on the heart through its diuretic and blood pressure lowering actions.
Exercise intolerance is a cardinal symptom of patients with HF and improving insulin sensitivity has been shown to improve exercise capacity. SGLT2 inhibition has been shown to improve insulin sensitivity and to reduce weight and therefore has the potential to improve exercise capacity in HF.
This study will assess the potential beneficial effects of the oral SGLT2 inhibitor, dapagliflozin, on LV remodelling and exercise capacity in patients with diabetes and HF. The findings of this study may help to establish the utility of SGLT2 inhibitors in diabetic patients with HF and provide important clinical data on the impact of SGLT2 inhibition on LV remodelling.
5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 56 is below the median of 72 across 3,737 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Dundee is the lead sponsor of 111 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dapagliflozin 10mg once daily
Drug: Dapagliflozin
Capsules containing microcrystalline cellulose Ph Eur overencapsulated in a hard gelatine capsule shell to match the active comparator
Drug: Placebo
Sodium Glucose Linked Transporter Type 2 (SGLT-2) Inhibitor
Also known as: Forxiga
Capsules containing microcrystalline cellulose Ph Eur overencapsulated in a hard gelatine capsule shell to match the active comparator
Change in LV end systolic volume (absolute value and indexed for BSA) or LV end diastolic volume (absolute value and indexed for BSA)
Cardiac MRI will be performed to determine the change in end systolic and diastolic volumes between both groups of patients
Time frame: 1 year
Change in LV mass, LV ejection fraction, RV end diastolic volume, RV end systolic volume, RV ejection fraction, atrial dimensions and volumes, and LV remodelling index (LV mass / LVEDV)
MRI will be performed to study the effects of the intervention on various other cardiac parameters.
Time frame: 1 year
Fluid status (Bioelectrical Impedence Analysis (BIA)
Bioelectrical Impedence Analysis (BIA) will be conducted to determine the effect of the study dug on overall fluid balance
Time frame: 1 year
Objective functional capacity (6 Minute Walk Test (6MWT)
6 Minute Walk Test (6MWT) will be performed to objectively determine the functional capacity of participants
Time frame: 1 year
Exercise capacity (Cardio-pulmonary Exercise Testing (CPET)
Cardio-pulmonary Exercise Testing (CPET) will be performed to determine the exercise capacity of participants
Time frame: 1 year
Quality of life (Minnesota Living with Heart Failure and SF-36 questionnaire)
will be conducted to determine the impact of the intervention on subjective quality of life
Time frame: 1 year
Cardiac and inflammatory biomarkers
Brain natriuretic peptide (BNP) and other inflammatory \& oxidative stress markers will be measured
Time frame: 1 year
Diuretic requirement (total diuretic requirement to maintain euvolemia)
The total diuretic requirement to maintain euvolemia will be compared between the beginning and end of the trial
Time frame: 1 year
Change in degree of microalbuminuria
Urinary analysis will be performed to determine if there has been any change in the severity of microalbuminuria
Time frame: 1 year
Quantify amount of natriuresis
Urinary analysis will be performed to quantify the amount of sodium excretion.
Time frame: 1 year
The safety of dapagliflozin use in diabetic, heart failure patients with regard to worsening HF, hospitalization and death will be evaluated
Time frame: 1 year
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Dundee