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Effects of Canagliflozin on Intravascular Volume and Hemodynamics

Cardiovascular Diseases Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Mechanistic Study to Evaluate the Effects of Canagliflozin on Intravascular Volume and Hemodynamics in Subjects With Type 2 Diabetes Mellitus and Heart Failure

Clinical Trial Summary

RESEARCH HYPOTHESIS

- In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4 weeks.

- Treatment with canagliflozin will be well tolerated over 4 weeks.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study (Figure 1). Thirty subjects will be randomized in a 3:2 randomization ratio to canagliflozin 300 mg once daily (QD) or placebo. The study will include a 3-week pretreatment screening phase and a 4-week double-blind treatment phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03190798
Study type Interventional
Source The University of Texas Health Science Center at San Antonio
Contact
Status Withdrawn
Phase Phase 4
Start date September 1, 2017
Completion date August 1, 2018
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