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Clinical Trial Summary

The investigators propose a small pilot proof of concept study to not only prove the existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin in patients with heart failure. The investigators propose a 50 patient randomized, double-blind, placebo-controlled crossover study with patients with stable HF, type II diabetes and an eGFR >45ml/min/1.73 m2 who are chronically receiving loop diuretics.


Clinical Trial Description

Study Objectives

1. Study the acute/short term effect and cardio-renal mechanisms of sodium-glucose cotransporter 2 (SGLT2) inhibition in patients with heart failure.

2. Determine the effect of chronic combined SLLGT2 and loop diuretic exposure in patients with heart failure.

Primary Outcomes

1. Aim 1 (Acute): Determine if acute SGLT2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo.

2. Aim 2 (Chronic): Determine the effect of 14 days of SGLT2 inhibition on blood volume. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03027960
Study type Interventional
Source Yale University
Contact
Status Completed
Phase Phase 1
Start date June 27, 2017
Completion date June 1, 2019

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