Dapagliflozin in PRESERVED Ejection Fraction Heart Failure

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Heart Failure With Preserved Systolic Function

In brief

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 chronic heart failure with preserved systolic function.

Key facts

Study ID

NCT03030235

Run by

Saint Luke's Health System

People needed

324

Starts

2017-03-01

Expected to finish

2021-08-13

Last updated by the study team

2022-10-19

Who can join

Age: 19 and older, up to 119. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 24 months of enrolment with no change in clinical status suggesting potential for deterioration in systolic function
• Elevated NT-proBNP (≥ 225 pg/ml) or BNP (≥ 75 pg/ml). For patients with permanent atrial fibrillation inclusion thresholds will be BNP ≥ 100 pg/mL or NTproBNP ≥ 375 pg/mL
• Stable medical therapy for heart failure for 15 days as defined by: i. No addition or removal of ACE, angiotensin receptor blockers (ARBs), valsartan/sacubitril, beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists; ii.No substantial change in dosage (100% or greater increase or decrease from baseline dose) of ACE, ARBs, beta-blockers, CCBs or aldosterone antagonists
• On a diuretic ≥15 days prior to screening visit and a stable diuretic therapy for 7 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 24 months prior to screening visit): a) 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 ≥55 mL or LA volume index ≥29 mL/m2 b) or left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness ≥1.1 cm.

You may not qualify if…

• Decompensated heart failure (hospitalization for heart failure within 7 days prior to screening)
• History of type 1 diabetes
• History of diabetic ketoacidosis
• Estimated glomerular filtration rate (eGFR) < 20 at the screening visit by modified MDRD equation GFR (mL/min/1.73 m2 ) = 175 x (Scr) -1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African American)
• Admission for an acute coronary syndrome (ST-elevation MI, non-ST-elevation MI, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 30 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 15 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 <75 pg/mL and NTproBNP<225 pg/mL at the screening visit. For patients with permanent atrial fibrillation exclusion thresholds will be BNP<100 pg/mL and NTproBNP<375pg/mL.
• Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) 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
• Current history of bladder cancer
• 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 be a primary contributor to dyspnea
• Isolated right heart failure due to pulmonary disease
• Active and significant ischemia thought to be a primary contributor to dyspnea
• Documentation of previous EF < 45%, under stable conditions, within the past 36 months
• Complex congenital heart disease
• Uncontrolled hypertension, defined as systolic blood pressure ≥200 mmHg during the screening visit (average value of three blood pressure measurements obtained in supine position)

Where it is running

• Heart Group of the Eastern Shore — Fairhope, Alabama, United States
• University of Southern California — Los Angeles, California, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Charlotte Heart Group Research Center — Port Charlotte, Florida, United States
• Emory University — Atlanta, Georgia, United States
• NorthShore University HealthSystem Research Insititute — Evanston, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• Chicago Medical Research — Hazel Crest, Illinois, United States
• OSF HealthCare Cardiovascular Institute — Peoria, Illinois, United States
• St. Vincent Cardiovascular Research Institute — Indianapolis, Indiana, United States
• Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• St. Francis Hospital — New York, New York, United States
• Eastern Nephrology Associates — New Bern, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Allegheny Health Network Research Institute — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Scott and White Research Institute — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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