• Overview
  • Eligibility
  • More info
  • Locations

Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With Type 2 Diabetes or Pre-diabetes, and PRESERVED Ejection Fraction Heart Failure (NCT03030235)

The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure, disease specific biomarkers, symptoms, health status and quality of life in patients with type 2 diabetes or prediabetes and chronic heart failure with preserved systolic function.
  • Drug: Dapagliflozin 10Mg Oral Tablet
    Dapagliflozin 10Mg Oral Tablet
    • Farxiga
  • Drug: Dapagliflozin matching placebo
    Dapagliflozin matching placebo
    • Placebo Oral Tablet
Ages eligible for Study
19 Years to 119 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Documented type 2 diabetes for at least 3 months, or prediabetes. Those with type 2 diabetes must be prescribed a lifestyle intervention alone or in combination with a stable dose(s) of at least one glucose-lowering medication during the 8 weeks prior to the screening visit.
  • Hemoglobin A1c inclusion criteria as follows: i. Hemoglobin A1c of 6-11% (inclusive) for patients with documented type 2 diabetes receiving metformin monotherapy; ii. Hemoglobin A1c of 6.5-11% (inclusive) for patients with documented type 2 diabetes receiving any type of glucose-lowering medication (except metformin monotherapy); iii. Hemoglobin A1c of 6.0-6.9% (inclusive) for patients with documented type 2 diabetes receiving lifestyle intervention alone; iv. Hemoglobin A1c of > 5.7% and < 6.5 % for patients with pre-diabetes
  • Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
  • Ejection fraction (EF) ≥ 45% as determined on imaging study within 18 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function
  • Elevated NT-proBNP ≥ 300 pg/ml or BNP ≥ 100 pg/ml. For patients with permanent atrial fibrillation inclusion thresholds will be BNP ≥ 125 pg/mL or NTproBNP ≥ 500 pg/mL
  • Stable medical therapy for heart failure for 30 days
  • On a diuretic ≥30 days prior to screening visit and a stable diuretic therapy for 14 days
  • At least one of the following: i. Hospitalization for decompensated HF in the last 12 months; ii. Acute treatment for HF with intravenous loop diuretic or hemofiltration in the last 12 months; iii. Mean pulmonary capillary wedge pressure ≥15 mmHg or LV end diastolic pressure (LVEDP) ≥15 mmHg documented during catheterization at rest, or pulmonary capillary wedge pressure or LVEDP ≥25 mmHg documented during catheterization with exercise; iv. Structural heart disease evidenced by at least one of the following echo findings (any local measurement made within the 18 months prior to screening visit): 1) left atrial (LA) enlargement defined by at least one of the following: LA width ≥3.8cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55mL or LA volume index ≥29 mL/m2 2) OR left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness ≥1.1 cm.
Exclusion Criteria:
  • Decompensated heart failure (hospitalization for heart failure within the 30 days prior to screening)
  • History of type 1 diabetes
  • History of diabetic ketoacidosis
  • Hemoglobin A1c <5.7 or >11% at the screening visit
  • Estimated glomerular filtration rate (eGFR) < 30 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.
  • Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
  • 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 transcatheter aortic valve replacement) or CRT 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 30 days of the screening visit.
  • History of hypersensitivity to dapagliflozin
  • 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
  • BNP <100 pg/mL and NTproBNP<300 pg/mL at the screening visit. For patients with permanent atrial fibrillation exclusion thresholds will be BNP<125 pg/mL and NTproBNP<500pg/mL.
  • 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 <100 mmHg at the screening or randomization visit
  • Past or current history of bladder cancer
  • Active Hematuria
  • Donation of blood or bone marrow 12 weeks prior to the screening visit and no planned donations during the study period
  • Heart failure due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and HOCM (hypertrophic obstructive cardiomyopathy).
  • Heart failure due to severe aortic or mitral regurgitation
  • Severe COPD thought to contribute to dyspnea
  • Isolated right heart failure due to pulmonary disease
  • Active and significant ischemia thought to contribute to dyspnea
  • Documentation of previous EF < 40% at any time
  • Complex congenital heart disease
  • Uncontrolled hypertension, defined as systolic blood pressure ≥200 mmHg during the screening visit
  • Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements
  • Bariatric surgery within the past 6 months or planned bariatric surgery within the study time course.
  • CardioMems device implantation within previous 4 weeks or planned CardioMems implantation during study period
  • For echo substudy only: history of poor echo windows as judged by the investigator
  • For echo substudy only: patients with ventricular paced rhythm or left bundle branch block on the most recent clinically available 12-lead electrocardiogram.
  • For echo substudy only: permanent atrial fibrillation
A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (NTproBNP and BNP), symptoms, health status, and quality of life in patients with type 2 diabetes or prediabetes and chronic heart failure with preserved systolic function. An imaging substudy will also be conducted to explore the effects of dapagliflozin vs. placebo on various echocardiographic parameters.

2 locations

United States (2)
  • Emory University
    recruiting
    Atlanta, Georgia, United States, 30303
  • Saint Luke's Mid America Heart Institute
    recruiting
    Kansas City, Missouri, United States, 64111
Status:
recruiting
Type:
Interventional
Phase:
Start:
01 March, 2017
Updated:
06 June, 2017
Participants:
320
Apply
A girl giving information about available additional trials.

FindMeCure helps you find, understand and join clinical trials from all over the world.

There are more clinical trials for your condition!