Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects

NCT03485092 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-09-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Empagliflozin 10 MG

Empagliflozin 10mg tablets for oral self administration once a day

DRUG

Placebo Oral Tablet

placebo tablets for oral self administration once a day

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER
  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Naveed Sattar, PhD · Glasgow University and NHS GGC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2020-03-28
Completion
2020-03-28

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03485092 on ClinicalTrials.gov