Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects

Sponsor
NHS Greater Glasgow and Clyde
Study ID
NCT03485092
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Empagliflozin 10mg tablets for oral self administration once a day
  • Placebo Oral Tablet — DRUG
    placebo tablets for oral self administration once a day

Study Details

The investigators hypothesise that empagliflozin 10mg daily will have haemodynamic, cardiac, and renal benefits compared to placebo over 36 weeks in heart failure patients with type 2 diabetes (or pre-diabetes), leading to measurable improvements in clinical measures of cardiac structure and function (LVESVI, and LV strain) as well as renal blood flow.

Key Dates

Start date
Mar 16, 2018
Status verified
Sep 2020
Primary completion
Mar 28, 2020
Completion
Mar 28, 2020

Study Design

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

Arms

  • Active Comparator: Empagliflozin
    Empagliflozin 10mg tablets for oral self-administration once daily
  • Placebo Comparator: Placebo Oral Tablet
    placebo tablets for oral self-administration once daily

Primary Outcome Measure

Left Ventricular End Systolic Volume Index (LVESVI) [ Time Frame: 36 weeks ]

Related Studies