EMPA Acute Heart Failure

NCT03554200 | Terminated Phase 2

• 2 other identifiers: 15-1562017-002695-45
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin on heart failure hospitalization in the EMPA-REG OUTCOME trial, the investigators do expect a similar beneficial effect to be present in patients with acute heart failure. Acute heart failure is a state of hydropic decompensation resulting in dyspnea and congestions, caused by different etiologies of cardiac disease. Recompensation is reached by application of diuretic drugs and fluid restriction.

Conditions

Diabetes Mellitus, Type 2; Acute Heart Failure

Keywords

Empagliflozin; acute heart failure; cardiac output; left ventricular systolic and diastolic function; exercise capacity

Outcome Measures

Primary Outcomes (1)

• effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure

  by ClearSight System

  30 days

Secondary Outcomes (28)

• Hemodynamics

  30 days

• Hemodynamics

  30 days

• Exercise Capacity

  30 days

• Cardio vascular

  30 days

• Effect of Empagliflozin on systemic quality of life

  30 days

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Patients will receive empagliflozin 10 mg qd for a period of 30 days.

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

Patients of the placebo arm will receive placebo tablets qd for a period of 30 days.

Drug: Placebo

Interventions

Empagliflozin DRUG

Standard of Care + Empagliflozin: 10 mg (tablets) once daily

Also known as: Jardiance

Empagliflozin

Placebo DRUG

Standard of Care + Placebo: Matching Placebo (tablets) once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients with acute heart failure with associated signs or symptoms (dyspnea on exertion, orthopnea, paroxysmal dyspnea, peripheral oedema, chest x-ray with pulmonary congestion)
• Serum levels of NT-proBNP ≥ 1000 pg/ml within 48 hours of Informed Consent
• Written informed consent prior to study participation

You may not qualify if:

• Type 1 diabetes
• Participants of child-bearing age without adequate contraception
• Pregnancy or lactating females
• Cardiogenic shock
• Acute coronary syndrome within 30 days prior to randomization
• Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
• Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH ≤ 7.30 and glucose \>14 mmol/l and HCO3- ≤ 18 mmol/l)
• Signs of uncontrolled active infection
• Dyspnea due to non-cardiac causes (severe pulmonary disease, anemia, severe obesity), non-HF causes such as acute or chronic respiratory disorders
• Coronary artery disease with requirement for revascularization within the study period
• Renal impairment (GFR \< 20 ml/min/1,73 m2)
• Known hepatic impairment (as evidenced by total bilirubin \>3 mg/dL) or history of cirrhosis with evidence of portal hypertension (e.g., presence of esophageal varices)
• Uncontrolled thyroid disease
• Endocrinopathies like Graves' disease, acromegaly, Cushings' disease
• Hypertensive retinopathy or encephalopathy

Sponsors & Collaborators

• RWTH Aachen University: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Department of Internal Medicine I RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This trial is double-blinded. After randomization neither the patients nor the investigator will be aware of the treatment allocation. Patients assigned to one of the double-blinded treatment will take one tablet Empagliflozin or matching placebo. The tablets will be identical in appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, prospective, placebo-controlled, double blind, randomized, 2-arm parallel, interventional, exploratory pilot study

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 13, 2018
• Study Start: June 11, 2018
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)