Safety and Effectiveness of SGLT-2 Inhibitors in Patients With Heart Failure and Diabetes

Sponsor
University of Dundee
Study ID
NCT02397421
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Sodium Glucose Linked Transporter Type 2 (SGLT-2) Inhibitor
  • Placebo — DRUG
    Capsules containing microcrystalline cellulose Ph Eur overencapsulated in a hard gelatine capsule shell to match the active comparator

Study Details

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)

Key Dates

Start date
Mar 31, 2015
Status verified
Jul 2018
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment
    Dapagliflozin 10mg once daily
  • Placebo Comparator: Control
    Capsules containing microcrystalline cellulose Ph Eur overencapsulated in a hard gelatine capsule shell to match the active comparator

Primary Outcome Measure

Change in LV end systolic volume (absolute value and indexed for BSA) or LV end diastolic volume (absolute value and indexed for BSA) [ Time Frame: 1 year ]

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