NCT03027960

Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure
• Type II; Diabetes

Interventions

Type	Name	Description
DRUG	Empagliflozin	10mg empagliflozin for a 2-week period
DRUG	Placebo Oral Capsule	10 mg placebo for a 2-week period

Timeline

• Start date: 2017-06-27
• Primary completion: 2019-05-14
• Completion: 2019-06-01
• First posted: 2017-01-23
• Last updated: 2020-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study