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Empagliflozin Impact on Hemodynamics in Patients With Diabetes and Heart Failure (EMBRACE-HF)

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ClinicalTrials.gov Identifier: NCT03030222
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Saint Luke's Health System

Brief 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 type 2 diabetes and 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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Empagliflozin 10Mg Tab Drug: Placebo Oral Tablet Phase 4

Detailed Description:
A 12-week randomized, double-blind, placebo-controlled trial to explore the effects of once-daily empagliflozin 10mg on hemodynamic parameters (pulmonary artery pressures) in patients with type 2 diabetes mellitus and 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Empagliflozin Evaluation by Measuring Impact on Hemodynamics in Patients With Diabetes and Heart Failure
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Empagliflozin
Empagliflozin 10 mg tab, once daily, for 12 weeks
Drug: Empagliflozin 10Mg Tab
Empagliflozin 10Mg Tab
Other Name: Jardiance

Placebo Comparator: Placebo
Empagliflozin matching placebo oral tablet, once daily for 12 weeks
Drug: Placebo Oral Tablet
Empagliflozin matching placebo
Other Name: Placebo




Primary Outcome Measures :
  1. To compare the change in pulmonary artery diastolic pressure from baseline to end of treatment period between empagliflozin and placebo [ Time Frame: Baseline to Weeks 8-12 ]
    To compare the change in pulmonary artery diastolic pressure from baseline to end of treatment period between empagliflozin and placebo


Secondary Outcome Measures :
  1. To compare change from baseline in pulmonary artery diastolic pressure between empagliflozin and placebo at each interim time point [ Time Frame: Baseline to Weeks 1-12 ]
    To compare change from baseline in pulmonary artery diastolic pressure between empagliflozin and placebo at each interim time point

  2. To compare change in pulmonary artery systolic pressure from baseline to end of treatment period between empagliflozin and placebo [ Time Frame: Baseline to Week 12 ]
    To compare change in pulmonary artery systolic pressure from baseline to end of treatment period between empagliflozin and placebo

  3. To compare change from baseline in pulmonary artery systolic pressure between empagliflozin and placebo at each interim time point [ Time Frame: Baseline to Weeks 1-12 ]
    To compare change from baseline in pulmonary artery systolic pressure between empagliflozin and placebo at each interim time point

  4. To compare change in mean pulmonary artery pressure from baseline to end of treatment period between empagliflozin and placebo [ Time Frame: Baseline to Week 12 ]
    To compare change in mean pulmonary artery pressure from baseline to end of treatment period between empagliflozin and placebo

  5. To compare change from baseline in mean pulmonary artery pressure between empagliflozin and placebo at each interim time point [ Time Frame: Baseline to Weeks 1-12 ]
    To compare change from baseline in mean pulmonary artery pressure between empagliflozin and placebo at each interim time point

  6. To compare change from baseline to follow-up in heart failure related quality of life between empagliflozin and placebo, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score. [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare change from baseline to follow-up in heart failure related quality of life between empagliflozin and placebo, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.

  7. To compare proportion of patients with a ≥ 5pts increase from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare proportion of patients with a ≥ 5pts increase from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo

  8. To compare change in 6 minute walk test from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare change in 6 minute walk test from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo

  9. To compare change in NTproBNP from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare change in NTproBNP from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo

  10. To compare change in BNP from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare change in BNP from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo

  11. To compare proportion of patients with a ≥ 20% decrease from baseline in NTproBNP at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare proportion of patients with a ≥ 20% decrease from baseline in NTproBNP at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo.

  12. To compare proportion of patients with a ≥ 20% decrease from baseline in BNP at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare proportion of patients with a ≥ 20% decrease from baseline in BNP at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo.

  13. To compare proportion of patients with both a ≥ 5pts increase from baseline in KCCQ and a ≥ 20% decrease from baseline in NTproBNP at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare proportion of patients with both a ≥ 5pts increase from baseline in KCCQ and a ≥ 20% decrease from baseline in NTproBNP at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo

  14. To compare the number of diuretic medication adjustments during the treatment period between empagliflozin and placebo [ Time Frame: Baseline to Week 12 ]
    To compare the number of diuretic medication adjustments during the treatment period between empagliflozin and placebo

  15. To compare change in Hemoglobin A1c from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo [ Time Frame: Baseline to Week 6 and Week 12 ]
    To compare change in Hemoglobin A1c from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 119 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 and <120 at the screening visit
  2. Documented type 2 diabetes, treated with at least one glucose-lowering medication (oral, noninsulin injectables, or insulin) with a stable dose(s) during the 12 weeks prior to the screening visit and no changes between the screening and randomization visits. Changes in sliding scale insulin dose are not considered to be a disqualifying change in insulin dose. Changes in total daily dose of insulin of ≤10% of the baseline total daily dose are not considered to be a disqualifying change in insulin dose.
  3. Hemoglobin A1c ≥6.5% and ≤11% at the screening visit
  4. Established diagnosis of heart failure (for at least 16 weeks prior to the screening visit) with either preserved (LVEF>40%) or reduced systolic function (LVEF≤40%), due to either ischemic or non-ischemic etiology, documented by an imaging modality (echocardiography, nuclear imaging, LV angiography, magnetic resonance imaging) within the past 24 months.
  5. No major change in diuretic management for 1 week prior to screening visit or between the screening and randomization visit (major change defined by doubling of diuretic dose or addition of another diuretic medication)
  6. NYHA class II, III or IV heart failure symptoms at the screening and randomization visit
  7. Presence of previously (≥ 4 weeks prior to screening visit) implanted CardioMEMs pulmonary artery pressure monitor for a clinical indication unrelated to the study.
  8. PA diastolic pressure ≥ 12 mmHg at the time of the screening visit (last measurement available prior to the screening visit).
  9. Ability to provide informed consent prior to initiating screening visit procedures

Exclusion Criteria:

  1. Decompensated heart failure (hospitalization for heart failure within the 4 weeks prior to screening) or between screening and randomization
  2. History of type 1 diabetes
  3. Hemoglobin A1c >11% or <6.5% at the screening visit
  4. Major change in diuretic management during 1 week prior to screening visit or between the screening and randomization visit. (major change defined by doubling of diuretic dose or addition of another diuretic medications)
  5. Significant variability in baseline PA diastolic pressures during screening period. Defined as changes greater than +/- 6 mmHg from average PA diastolic pressure during week 1 of the screening phase and average PA diastolic pressure during week 2 of the screening phase for those patients with an average baseline PA diastolic pressure during week 1 of the screening phase of <30 mmHg. If the average baseline PA diastolic pressure during week 1 of the screening phase is ≥30 mmHg, then ≥20% relative change in average PA diastolic pressure between week 1 and week 2 of the screening phase will be used to define significant variability.
  6. Initiation of hydralazine, long-acting nitrates, beta blockers, ACEI/ARBs or Valsartan/sacubitril in the prior 4 weeks prior to screening
  7. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at the screening visit
  8. Admission for an acute coronary syndrome (ST-elevation MI, non-ST-elevation MI, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 60 days prior to the screening visit.
  9. Implantation of cardiac resynchronization therapy (CRT) device within the previous 90 days.
  10. Implantation of the CardioMEMs device within the past 4 weeks.
  11. Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy), or planned implantation of CRT device within the 90 days after the screening visit.
  12. Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within the 12 weeks prior to the screening visit.
  13. History of hypersensitivity to empagliflozin
  14. For women of child-bearing potential: Current or planned pregnancy or currently lactating
  15. Life expectancy <1 year at the screening visit
  16. Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
  17. PA diastolic pressure < 12 mmHg at the time of the screening visit (average of last four measurements available prior to the screening visit).
  18. Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 12 weeks prior to the screening visit.
  19. Average supine systolic BP <90 mmHg at the screening or randomization visit
  20. Past or current documented history of bladder cancer
  21. Active Gross Hematuria
  22. Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and HOCM (hypertrophic obstructive cardiomyopathy).
  23. History of heart transplant.
  24. Patients on heart transplant list as 1a and 1b status

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): NCT03030222


Contacts
Contact: Sheryl Windsor 8169329858 EMBRACE-HF@saint-lukes.org

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Study Coordinator    323-442-7983      
United States, Florida
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32256
Contact: Study Coordinator    904-493-3333      
United States, Minnesota
CentraCare Heart and Vascular Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Study Coordinator    320-251-2700 ext 58482      
United States, New York
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Study Coordinator    516-562-6790      
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Study Coordinator    614-247-7133      
United States, Texas
Austin Heart Clinical Research Recruiting
Austin, Texas, United States, 78756
Contact: Study Coordinator    512-206-3602      
United States, Virginia
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Study Coordinator    757-388-2732      
Sponsors and Collaborators
Saint Luke's Health System
Investigators
Study Chair: Mikhail Kosiborod, MD Saint Luke's Mid America Heart Institute

Additional Information:
Responsible Party: Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT03030222     History of Changes
Other Study ID Numbers: 1245.129
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Saint Luke's Health System:
diabetes
heart failure
empagliflozin
SGLT-2 inhibitors

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs