Dapagliflozin in Patients with HF
Research type
Research Study
Full title
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Ejection Fraction
IRAS ID
225744
Contact name
Robert Hunter
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-003897-41
Duration of Study in the UK
3 years, 6 months, 16 days
Research summary
Heart failure affects approximately 38 million people worldwide and continues to be a major cause of death, hospitalisation, and poor quality of life. Dapagliflozin reduces glucose reabsorption from the kidney back into the bloodstream, resulting in less glucose circulating in the blood, which has been shown to lead to a reduction in body weight and blood pressure, which are known risk factors for the progression of heart failure. It is thought that dapagloflozin therefore provides protection for the heart.\nAstraZeneca are evaluating the effect of dapagliflozin in this event-driven study, lasting approximately 33 months, to see whether type II diabetic and non-diabetic patients with an established diagnosis of chronic heart failure, and at high risk of cardiovascular death or heart failure events, have a reduction in the worsening of their condition during the study; specifically whether dapagliflozin reduces the incidence of cardiovascular death or a heart failure event (hospitalization for heart failure or equivalent heart failure event, ie an urgent HF visit). We will also be looking at patients’ overall symptoms and physical limitations in addition to the safety and tolerability of dapagliflozin. Patients will be automatically assigned to either the dapagliflozin tablets or placebo (sugar) tablets at the start of the study and the treatment each patient receives will not be known to AstraZeneca or their doctor. After providing written consent, study patients will have their medical history reviewed, have an ECG, blood tests and vital signs taken, complete quality of life questionnaires and have physical examinations performed to check on their overall health and wellbeing. Following enrolment into the study, visits will be completed at 14 days, 60 days, 120 days, 240 days, 360 days and then every 4 months thereafter until the study closes.
REC name
West of Scotland REC 1
REC reference
17/WS/0069
Date of REC Opinion
5 May 2017
REC opinion
Further Information Favourable Opinion