Empagliflozin Impact on Hemodynamics in Patients With Heart Failure
NCT ID: NCT03030222
Last Updated: 2021-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
65 participants
INTERVENTIONAL
2017-07-05
2020-03-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Empagliflozin
Empagliflozin 10 mg tab, once daily, for 12 weeks
Empagliflozin 10 mg Tab
Empagliflozin 10 mg Tab
Placebo
Empagliflozin matching placebo oral tablet, once daily for 12 weeks
Placebo Oral Tablet
Empagliflozin matching placebo
Interventions
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Empagliflozin 10 mg Tab
Empagliflozin 10 mg Tab
Placebo Oral Tablet
Empagliflozin matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No major change in diuretic management for 48 hours prior to screening visit or 48 hours prior to randomization visit (major change defined by doubling of diuretic dose or addition of another diuretic medication)
3. New York Heart Association (NYHA) class II, III or IV heart failure symptoms at the screening and randomization visit
4. Presence of previously (≥ 2 weeks prior to screening visit) implanted CardioMEMs pulmonary artery pressure monitor for a clinical indication unrelated to the study.
5. Pulmonary artery diastolic pressure ≥ 12 mmHg at the time of the screening visit (last measurement available prior to the screening visit).
6. Ability to provide informed consent prior to initiating screening visit procedures
Exclusion Criteria
2. History of type 1 diabetes
3. Major change in diuretic management during 48 hours prior to screening visit or 48 hours prior to randomization visit. (major change defined by doubling of diuretic dose or addition of another diuretic medications)
4. Significant variability in baseline pulmonary artery diastolic pressures during screening period. Defined as changes greater than +/- 6 mmHg from average pulmonary artery diastolic pressure during week 1 of the screening phase and average pulmonary artery diastolic pressure during week 2 of the screening phase for those patients with an average baseline pulmonary artery diastolic pressure during week 1 of the screening phase of \<30 mmHg. If the average baseline pulmonary artery diastolic pressure during week 1 of the screening phase is ≥30 mmHg, then ≥20% relative change in average pulmonary diastolic pressure between week 1 and week 2 of the screening phase will be used to define significant variability.
5. Initiation of hydralazine, long-acting nitrates, beta blockers, angiotensin-converting enzyme inhibitors (ACEIs) , angiotensin II receptor blockers (ARBs) or valsartan/sacubitril in the prior 4 weeks prior to screening
6. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 at the screening visit
7. Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 30 days prior to the screening visit.
8. Implantation of cardiac resynchronization therapy (CRT) device within the previous 90 days.
9. Implantation of the CardioMEMs device within the past 2 weeks.
10. 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 cardiac resynchronization therapy (CRT) device within the 90 days after the screening visit.
11. Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within the 4 weeks prior to the screening visit.
12. History of hypersensitivity to empagliflozin
13. For women of child-bearing potential: Current or planned pregnancy or currently lactating
14. Life expectancy \<1 year at the screening visit
15. Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
16. Pulmonary artery diastolic pressure \< 12 mmHg at the time of the screening visit (average of last four measurements available prior to the screening visit).
17. Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 8 weeks prior to the screening visit
18. Average supine systolic BP \<90 mmHg at the screening or randomization visit
19. Current documented history of bladder cancer
20. Active Gross Hematuria
21. Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and hypertrophic obstructive cardiomyopathy (HOCM).
22. History of heart transplant.
23. Patients on heart transplant list as 1a and 1b status
19 Years
119 Years
ALL
No
Sponsors
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Saint Luke's Health System
OTHER
Responsible Party
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Principal Investigators
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Mikhail Kosiborod, MD
Role: STUDY_CHAIR
Saint Luke's Mid America Heart Institute
Locations
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University of Southern California
Los Angeles, California, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
NorthShore University Health System Research Institute
Evanston, Illinois, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
St. Francis Hospital
Roslyn, New York, United States
Ohio State University
Columbus, Ohio, United States
Sanford Research
Sioux Falls, South Dakota, United States
Austin Heart Clinical Research
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Countries
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References
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Nassif ME, Qintar M, Windsor SL, Jermyn R, Shavelle DM, Tang F, Lamba S, Bhatt K, Brush J, Civitello A, Gordon R, Jonsson O, Lampert B, Pelzel J, Kosiborod MN. Empagliflozin Effects on Pulmonary Artery Pressure in Patients With Heart Failure: Results From the EMBRACE-HF Trial. Circulation. 2021 Apr 27;143(17):1673-1686. doi: 10.1161/CIRCULATIONAHA.120.052503. Epub 2021 Feb 8.
Nassif ME, Spertus JA, Tang F, Windsor SL, Jones P, Thomas M, Khariton Y, Brush J, Gordon RA, Jermyn R, Jonsson O, Lamba S, Shavelle DM, Kosiborod MN. Association Between Change in Ambulatory Hemodynamic Pressures and Symptoms of Heart Failure. Circ Heart Fail. 2021 Nov;14(11):e008446. doi: 10.1161/CIRCHEARTFAILURE.121.008446. Epub 2021 Oct 26. No abstract available.
Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Empagliflozin information
Other Identifiers
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1245.129
Identifier Type: -
Identifier Source: org_study_id