EUCTR2017-001341-27-DK
Active, not recruiting
Phase 1
Empagliflozin in heart failure patients with reduced ejection fraction:A randomized clinical trial (Empire HF)
Morten Schou0 sites190 target enrollmentApril 10, 2017
DrugsJardiance
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Morten Schou
- Enrollment
- 190
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Optimal Heart Failure Therapy in accordance with European and National Guidelines
- •(3\) LVEF \= 0\.40
- •(4\) eGFR \> 30 ml/min/1\.73 m2
- •(5\) BMI \< 45 kg/m2
- •(6\) NYHA class I\-III
- •(7\) Age \> 18 years
- •(8\) If T2D – optimal treatment in accordance with European and National Guidelines
- •(9\) If T2D – stable doses of antiglycemic treatment for 30 days
- •(10\) If T2D – HbA1C 6\.5\-10 %
- •Are the trial subjects under 18? no
Exclusion Criteria
- •(1\) CRT\-D/\-P implanted \< 90 days
- •(2\) Uncorrected severe valvular disease
- •(3\) Non\-compliance
- •(4\) Use of metalozone
- •(5\) NYHA IV
- •(6\) Age \> 85 years
- •(7\) Dementia
- •(8\) Admission for HF \< 30 days
- •(9\) Admission for hypoglycemia \< 12 month
- •(10\) Known sustained VT
Outcomes
Primary Outcomes
Not specified
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