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Dapagliflozin in Type 2 Diabetes or Pre-diabetes, and PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF)

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ClinicalTrials.gov Identifier: NCT03030235
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

January 20, 2017
January 24, 2017
April 2, 2018
March 1, 2017
December 2018   (Final data collection date for primary outcome measure)
Change from baseline in NTproBNP at 6 and 12 weeks [ Time Frame: Baseline to Week 6 and Week 12 ]
Change from baseline in NTproBNP at 6 and 12 weeks
Change from baseline in NTproBNP at 6 and 12 weeks. [ Time Frame: Baseline to Week 6 and Week 12 ]
Complete list of historical versions of study NCT03030235 on ClinicalTrials.gov Archive Site
  • Change from baseline in heart failure related quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score over the treatment period [ Time Frame: Baseline to Week 12 ]
    Change from baseline in heart failure related quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score over the treatment period
  • Change from baseline in 6 minute walk test over the treatment period [ Time Frame: Baseline to Week 12 ]
    Change from baseline in 6 minute walk test over the treatment period
  • Change from baseline in BNP over the treatment period [ Time Frame: Baseline to Week 12 ]
    Change from baseline in BNP over the treatment period
  • Change from baseline in HbA1c over the treatment period [ Time Frame: Baseline to Week 12 ]
    Change from baseline in HbA1c over the treatment period
  • Proportion of patients with a ≥ 5pts increase in KCCQ [ Time Frame: Baseline to Week 12 ]
    Proportion of patients with a ≥ 5pts increase in KCCQ
  • Proportion of patients with a ≥ 20% decrease in NTproBNP [ Time Frame: Baseline to Week 12 ]
    Proportion of patients with a ≥ 20% decrease in NTproBNP
  • Proportion of patients with a ≥ 5pts increase in KCCQ and a ≥ 20% decrease in NTproBNP [ Time Frame: Baseline to Week 12 ]
    Proportion of patients with a ≥ 5pts increase in KCCQ and a ≥ 20% decrease in NTproBNP
  • Change in weight over 12 weeks [ Time Frame: Baseline to Week 12 ]
    Change in weight over 12 weeks
  • Change in systolic blood pressure over 12 weeks [ Time Frame: Baseline to Week 12 ]
    Change in systolic blood pressure over 12 weeks
  • Change from baseline in heart failure related quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score over the treatment period [ Time Frame: Baseline to Week 12 ]
  • Change from baseline in 6 minute walk test over the treatment period [ Time Frame: Baseline to Week 12 ]
  • Change from baseline in BNP over the treatment period [ Time Frame: Baseline to Week 12 ]
  • Change from baseline in HbA1c over the treatment period [ Time Frame: Baseline to Week 12 ]
  • Proportion of patients with a ≥ 5pts increase in KCCQ [ Time Frame: Baseline to Week 12 ]
  • Proportion of patients with a ≥ 20% decrease in NTproBNP [ Time Frame: Baseline to Week 12 ]
  • Proportion of patients with a ≥ 5pts increase in KCCQ and a ≥ 20% decrease in NTproBNP [ Time Frame: Baseline to Week 12 ]
  • Change in weight over 12 weeks [ Time Frame: Baseline to Week 12 ]
  • Change in systolic blood pressure over 12 weeks [ Time Frame: Baseline to Week 12 ]
Not Provided
Not Provided
 
Dapagliflozin in Type 2 Diabetes or Pre-diabetes, and PRESERVED Ejection Fraction Heart Failure
Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With Type 2 Diabetes or Pre-diabetes, and PRESERVED Ejection Fraction Heart Failure
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Heart Failure With Preserved Systolic Function
  • Drug: Dapagliflozin 10Mg Oral Tablet
    Dapagliflozin 10Mg Oral Tablet
    Other Name: Farxiga
  • Drug: Dapagliflozin matching placebo
    Dapagliflozin matching placebo
    Other Name: Placebo Oral Tablet
  • Active Comparator: Dapagliflozin
    Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks
    Intervention: Drug: Dapagliflozin 10Mg Oral Tablet
  • Placebo Comparator: Placebo
    Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks
    Intervention: Drug: Dapagliflozin matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
Same as current
March 2019
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. 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
  3. Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
  4. 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
  5. 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
  6. Stable medical therapy for heart failure for 30 days
  7. On a diuretic ≥30 days prior to screening visit and a stable diuretic therapy for 14 days
  8. 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:

  1. Decompensated heart failure (hospitalization for heart failure within the 30 days prior to screening)
  2. History of type 1 diabetes
  3. History of diabetic ketoacidosis
  4. Hemoglobin A1c <5.7 or >11% at the screening visit
  5. Estimated glomerular filtration rate (eGFR) < 30 at the screening visit
  6. 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.
  7. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
  8. 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.
  9. 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.
  10. History of hypersensitivity to dapagliflozin
  11. For women of child-bearing potential: Current or planned pregnancy or currently lactating.
  12. Life expectancy <1 year at the screening visit
  13. Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
  14. 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.
  15. 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.
  16. Average supine systolic BP <100 mmHg at the screening or randomization visit
  17. Past or current history of bladder cancer
  18. Active Hematuria
  19. Donation of blood or bone marrow 12 weeks prior to the screening visit and no planned donations during the study period
  20. Heart failure due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and HOCM (hypertrophic obstructive cardiomyopathy).
  21. Heart failure due to severe aortic or mitral regurgitation
  22. Severe COPD thought to contribute to dyspnea
  23. Isolated right heart failure due to pulmonary disease
  24. Active and significant ischemia thought to contribute to dyspnea
  25. Documentation of previous EF < 40% at any time
  26. Complex congenital heart disease
  27. Uncontrolled hypertension, defined as systolic blood pressure ≥200 mmHg during the screening visit
  28. 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
  29. Bariatric surgery within the past 6 months or planned bariatric surgery within the study time course.
  30. CardioMems device implantation within previous 4 weeks or planned CardioMems implantation during study period
  31. For echo substudy only: history of poor echo windows as judged by the investigator
  32. For echo substudy only: patients with ventricular paced rhythm or left bundle branch block on the most recent clinically available 12-lead electrocardiogram.
  33. For echo substudy only: permanent atrial fibrillation
Sexes Eligible for Study: All
19 Years to 119 Years   (Adult, Older Adult)
No
Contact: Sheryl Windsor 8169329858 PRESERVED-HF@saint-lukes.org
United States
 
 
NCT03030235
D1690C00053
Yes
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
Plan to Share IPD: Undecided
Saint Luke's Health System
Saint Luke's Health System
Not Provided
Study Chair: Mikhail Kosiborod, MD Saint Luke's Mid America Heart Institute
Saint Luke's Health System
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP