Saint Luke's Health System
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.
- Drug: Empagliflozin 10Mg TabEmpagliflozin 10Mg Tab
- Drug: Placebo Oral TabletEmpagliflozin matching placebo
|Ages eligible for Study||19 Years to 119 Years|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- Age > 18 and <120 at the screening visit
- 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.
- Hemoglobin A1c ≥6.5% and ≤11% at the screening visit
- 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.
- 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)
- NYHA class II, III or IV heart failure symptoms at the screening and randomization visit
- Presence of previously (≥ 4 weeks prior to screening visit) implanted CardioMEMs pulmonary artery pressure monitor for a clinical indication unrelated to the study.
- PA diastolic pressure ≥ 12 mmHg at the time of the screening visit (last measurement available prior to the screening visit).
- Ability to provide informed consent prior to initiating screening visit procedures
- Decompensated heart failure (hospitalization for heart failure within the 4 weeks prior to screening) or between screening and randomization
- History of type 1 diabetes
- Hemoglobin A1c >11% or <6.5% at the screening visit
- 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)
- 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.
- Initiation of hydralazine, long-acting nitrates, beta blockers, ACEI/ARBs or Valsartan/sacubitril in the prior 4 weeks prior to screening
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at the screening visit
- 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.
- Implantation of cardiac resynchronization therapy (CRT) device within the previous 90 days.
- Implantation of the CardioMEMs device within the past 4 weeks.
- 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.
- 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.
- History of hypersensitivity to empagliflozin
- For women of child-bearing potential: Current or planned pregnancy or currently lactating
- Life expectancy <1 year at the screening visit
- Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
- PA diastolic pressure < 12 mmHg at the time of the screening visit (average of last four measurements available prior to the screening visit).
- 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.
- Average supine systolic BP <90 mmHg at the screening or randomization visit
- Past or current documented history of bladder cancer
- Active Gross Hematuria
- Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and HOCM (hypertrophic obstructive cardiomyopathy).
- History of heart transplant.
- Patients on heart transplant list as 1a and 1b status
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.
United States (1)
- University of Southern CaliforniarecruitingLos Angeles, California, United States, 90033
04 July, 2017
13 July, 2017