NCT03030222

Empagliflozin Impact on Hemodynamics in Patients With Heart Failure

Empagliflozin Evaluation by Measuring Impact on Hemodynamics in Patients With Heart Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Saint Luke's Health System · Academic / Other
• Sex: All
• Age: 19 Years – 119 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device (a wireless hemodynamic monitoring system) implanted for non-study related clinical reasons.

Detailed description

A 12-week randomized, double-blind, placebo-controlled trial to explore the effects of once-daily empagliflozin 10 mg on hemodynamic parameters (pulmonary artery pressures) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device implanted for non-study related clinical reasons.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 mg Tab	Empagliflozin 10 mg Tab
DRUG	Placebo Oral Tablet	Empagliflozin matching placebo

Timeline

• Start date: 2017-07-05
• Primary completion: 2020-03-10
• Completion: 2020-03-10
• First posted: 2017-01-24
• Last updated: 2021-12-09
• Results posted: 2021-12-09

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study