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EMPA Acute Heart Failure

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ClinicalTrials.gov Identifier: NCT03554200
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Acute Heart Failure Drug: Empagliflozin Drug: Placebo Phase 2

Detailed Description:

In the present study patients will be randomized into 2 groups (standard of care + Empagliflozin 10 mg/d or standard of care + placebo). Cardiac output will be assessed by a medical device for noninvasive monitoring of hemodynamic parameters (cardiac output, systemic vascular resistance, stroke volume and blood pressure) using finger cuff technology for pulse contour analysis.

These investigations will inform about Empagliflozin dependent effects on hemodynamic and cardiac function in patients with acute heart failure. The investigation will further assess the therapeutic efficacy of Empagliflozin on heart failure symptoms using objective (respiratory rate, oxygen requirement, peak expiratory flow rate, urinary volume, body weight, diuretic requirement, length of hospital stay) and well accepted, patient orientated secondary endpoints. In addition, metabolic regulators and parameters relevant for cardiac function and substrate metabolism will be assessed to further investigate possible mechanisms of Empagliflozin-dependent actions on cardiac function.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, prospective, placebo-controlled, double blind, randomized, 2-arm parallel, interventional, exploratory pilot study
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effect of Empagliflozin on Cardiac Output in Patients With Acute Heart Failure (EMPA Acute Heart Failure)
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Empagliflozin
Patients will receive empagliflozin 10 mg qd for a period of 30 days.
Drug: Empagliflozin
Standard of Care + Empagliflozin: 10 mg (tablets) once daily
Other Name: Jardiance

Placebo Comparator: Placebo
Patients of the placebo arm will receive placebo tablets qd for a period of 30 days.
Drug: Placebo
Standard of Care + Placebo: Matching Placebo (tablets) once daily




Primary Outcome Measures :
  1. effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure [ Time Frame: 30 days ]
    by ClearSight System


Secondary Outcome Measures :
  1. Hemodynamics [ Time Frame: 30 days ]
    Stroke volume (ml/beat)

  2. Cardio vascular [ Time Frame: 30 days ]
    blood pressure (mmHg)

  3. Effect of Empagliflozin on systemic quality of life [ Time Frame: 30 days ]
    Quality of life questionnaire

  4. Effect of Empagliflozin on hospitalization due to cardiovascular causes or readmission for heart failure or renal failure [ Time Frame: 30 days ]
    length of initial hospital stay

  5. Effect of Empagliflozin on death due to cardiovascular causes [ Time Frame: 30 days ]
    days alive and out of hospital

  6. Urine [ Time Frame: 30 days ]
    24 h sodium excretion (mmol/day)

  7. Body weight [ Time Frame: 30 days ]
    body weight (kg)

  8. Cardio vascular [ Time Frame: 30 days ]
    24 h heart rate (bpm)

  9. Blood [ Time Frame: 30 days ]
    NT-proBNP (ng/l)

  10. Blood [ Time Frame: 30 days ]
    cystatin C(mg/dl)

  11. Blood [ Time Frame: 30 days ]
    serum levels of Glucose (mg/dl)

  12. Respiratory rate [ Time Frame: 30 days ]
    breaths/min

  13. Diuretic response [ Time Frame: 30 days ]
    Δ weight kg/[(total i.v. dose)/40mg]+[(total oral dose)/80mg)] furosemide

  14. Kidney injury risk score [ Time Frame: 30 days ]
    by NephroCheck® (defined by TIMP-2 x IGFBP7 in urine)

  15. change of microbiome [ Time Frame: 30 days ]
    stool sample



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Type 1 diabetes
  2. Participants of child-bearing age without adequate contraception
  3. Pregnancy or lactating females
  4. Cardiogenic shock
  5. Acute coronary syndrome within 30 days prior to randomization
  6. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
  7. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH ≤ 7.30 and glucose >14 mmol/l and HCO3- ≤ 18 mmol/l)
  8. Signs of active infection
  9. Dyspnea due to non-cardiac causes (severe pulmonary disease, anemia, severe obesity)
  10. Coronary artery disease with requirement for revascularization within the study period
  11. Renal impairment (GFR < 30 ml/min/1,73 m2)
  12. Liver disease (serum levels of AST, ALT or AP more than three times the upper limit of normal)
  13. Uncontrolled thyroid disease
  14. Endocrinopathies like Graves' disease, acromegaly, Cushings' disease
  15. Hypertensive retinopathy or encephalopathy
  16. Bariatric surgery in last 2 years prior to randomization
  17. Patients in whom study participation is not deemed appropriate under consideration of clinical wellbeing by the principal investigator
  18. The subject is mentally or legally incapacitated
  19. The subject received an investigational drug within 30 days prior to inclusion into this study
  20. Urinary tract infections or significant formation of residual urine in medical history
  21. Patients with particular risk for ketoacidosis (alcohol abuse, pancreatitis, pancreatic insulin deficiency from any cause, caloric restriction etc.) or ketoacidosis in the past
  22. Frequent hypoglycaemic events (in the opinion of the investigator)
  23. Intolerance to Empagliflozin and excipients in Empagliflozin or rather placebo

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554200


Contacts
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Contact: Michael Lehrke, Dr +49 241 8089301 mlehrke@ukaachen.de

Locations
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Germany
Department of Internal Medicine I RWTH Aachen University Hospital Recruiting
Aachen, NRW, Germany, 52074
Contact: Michael Lehrke, PD Dr. med.    +49 241 80 85152    mlehrke@ukaachen.de   
Principal Investigator: Michael Lehrke, PD Dr. med.         
Sub-Investigator: Nikolaus Marx, Univ.-Prof. Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
Boehringer Ingelheim

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03554200     History of Changes
Other Study ID Numbers: 15-156
2017-002695-45 ( EudraCT Number )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RWTH Aachen University:
Empagliflozin
acute heart failure
cardiac output
left ventricular systolic and diastolic function
exercise capacity

Additional relevant MeSH terms:
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Diabetes Mellitus
Heart Failure
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs