Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure

Sponsor
University Medical Center Groningen
Study ID
NCT03200860
Phase
PHASE2
Status
Completed

Conditions

  • Heart Failure Acute
  • Heart Failure; With Decompensation
  • Heart Failure，Congestive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    10 mg daily, oral, 30 days
  • Placebo Oral Tablet — DRUG
    Matching Placebo, 10 mg daily, oral, 30 days

Study Details

Acute decompensated heart failure is the fastest growing disease in the world and the leading cause of hospital admissions worldwide. Short term mortality and rehospitalization are extremely high (20-30% within 3-6 months) and there is no therapy available that improves clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose co-transporter with diuretic and renal- protective properties. In patients with type 2 diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of hospitalization for heart failure by 35%. Based on the promising pharmacological profile of empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure, with or without diabetes, This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.

Key Dates

Start date
Dec 18, 2017
Status verified
Apr 2024
Primary completion
Sep 18, 2019
Completion
Sep 18, 2019

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin
    Empagliflozin 10 mg daily, oral, 30 days
  • Placebo Comparator: Placebo
    Matching Placebo 10 mg daily, oral, 30 days

Primary Outcome Measure

Dyspnea [ Time Frame: From baseline to Day 4 ]

Related Studies