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Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects

NCT03027960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-06-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Empagliflozin

10mg empagliflozin for a 2-week period

DRUG

Placebo Oral Capsule

10 mg placebo for a 2-week period

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Testani, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2019-05-14
Completion
2019-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03027960 on ClinicalTrials.gov