CompletedNCT03030235PRESERVED-HFUpdated Oct 19, 2022Results posted

Dapagliflozin in PRESERVED Ejection Fraction Heart Failure

A Phase 4 interventional study of Dapagliflozin 10Mg Oral Tablet and Dapagliflozin matching placebo in Chronic Heart Failure With Preserved Systolic Function, sponsored by Saint Luke's Health System. Completed at 26 sites in United States. Open to participants aged 19 Years to 119 Years. Per ClinicalTrials.gov, last updated 2022-10-19.

Sponsored by Saint Luke's Health System · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 324
Allocation: Randomized
Ages: 19 Years to 119 Years
Sex: All

Study summary

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.

Read the detailed description

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 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.

Conditions studied

Chronic Heart Failure With Preserved Systolic Function

Browse trials for

Heart Failure 5,701

Keywords

heart failure
dapagliflozin
SGLT-2 inhibitors

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 324 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Saint Luke's Health System is the lead sponsor of 35 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 119 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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)
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: 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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 324 participants (actual)

Study arms

Active comparator
Dapagliflozin
Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks
Drug: Dapagliflozin 10Mg Oral Tablet
Placebo comparator
Placebo
Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks
Drug: Dapagliflozin matching placebo

Interventions

DrugDapagliflozin 10Mg Oral Tablet
Dapagliflozin 10Mg Oral Tablet
Also known as: Farxiga
DrugDapagliflozin matching placebo
Dapagliflozin matching placebo
Also known as: Placebo Oral Tablet

What researchers measure

Primary outcomes

Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)
Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12. The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12

Secondary outcomes

Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at Week 12. The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)
BNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance
6 minute walk test distance at 12 weeks. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c
Hemoglobin A1c at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS)
Proportion of patients with a ≥ 5 point increase in KCCQ-CS and KCCQ-OS at Week 12. The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For KCCQ-CS and KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
Proportion of patients with a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)
Proportion of patients with a ≥ 5 point increase in KCCQ-CS and a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on Weight
Weight at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12
Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure
Systolic blood pressure at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.
Time frame: Baseline to Week 12

Results

Posted Oct 19, 2022

Participant flow

Participant flow — Overall Study
Milestone	Dapagliflozin	Placebo
Started	162	162
Completed	146	145
Not completed	16	17

Outcome measures

PrimaryEffect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)

Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12. The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Mean · score on a scale

Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)
score on a scale	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)	68.6 (66.2 to 71.0)	62.8 (60.4 to 65.3)

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)

Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at Week 12. The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Mean · score on a scale

Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
score on a scale	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)	68.9 (66.5 to 71.3)	64.5 (62.1 to 66.8)

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)

NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Mean · pg/mL

Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
pg/mL	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)	733 (673 to 799)	739 (678 to 805)

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)

BNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Mean · pg/mL

Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)
pg/mL	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)	147 (136 to 160)	147 (136 to 160)

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance

6 minute walk test distance at 12 weeks. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Mean · meters

Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance
meters	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance	262 (252 to 272)	242 (232 to 252)

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c

Hemoglobin A1c at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Mean · Percent

Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c
Percent	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c	6.5 (6.4 to 6.6)	6.6 (6.5 to 6.7)

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS)

Proportion of patients with a ≥ 5 point increase in KCCQ-CS and KCCQ-OS at Week 12. The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For KCCQ-CS and KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Count of participants · Participants

Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS)
Participants	Dapagliflozin	Placebo
KCCQ-CS increase ≥ 5 points	69	53
KCCQ-OS increase ≥ 5 points	75	58

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)

Proportion of patients with a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Count of participants · Participants

Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
Participants	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)	48	44

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)

Proportion of patients with a ≥ 5 point increase in KCCQ-CS and a ≥ 20% decrease in NTproBNP at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Count of participants · Participants

Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)
Participants	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)	23	15

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on Weight

Weight at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Mean · kilograms

Effect of Dapagliflozin, as Compared With Placebo, on Weight
kilograms	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on Weight	101.3 (100.9 to 101.8)	102.1 (101.6 to 102.6)

SecondaryEffect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure

Systolic blood pressure at Week 12. Values have been adjusted for the corresponding baseline value, history of type 2 diabetes, sex, atrial fibrillation, baseline estimated glomerular filtration rate and left ventricular ejection fraction.

Time frame:: Baseline to Week 12
Reported as:: Mean · mm Hg

Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure
mm Hg	Dapagliflozin	Placebo
Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure	133 (130 to 135)	133 (131 to 136)

Adverse events

Collected over Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dapagliflozin	1/162 (0.6%)	31/162 (19.1%)	13/162 (8%)
Placebo	2/162 (1.2%)	22/162 (13.6%)	16/162 (9.9%)

Most frequent serious events

Showing 10 of 64

Most frequent serious events
Event	Dapagliflozin	Placebo
Exacerbation of Heart FailureCardiac disorders	14/162	6/162
Acute Kidney InjuryGeneral disorders	8/162	4/162
Atrial FibrillationCardiac disorders	3/162	0/162
CellulitisInfections and infestations	2/162	3/162
Chest PainGeneral disorders	0/162	2/162
Covid-19Infections and infestations	1/162	2/162
SepsisInfections and infestations	1/162	2/162
Suicidal IdeationGeneral disorders	2/162	0/162
Volume DepletionGeneral disorders	2/162	1/162
Abdominal Wall HematomaInjury, poisoning and procedural complications	1/162	0/162

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	Dapagliflozin	Placebo
Volume DepletionGeneral disorders	10/162	7/162
Urgent Heart Failure VisitCardiac disorders	8/162	8/162
NauseaGeneral disorders	1/162	0/162
Leg painMusculoskeletal and connective tissue disorders	1/162	0/162
Back PainMusculoskeletal and connective tissue disorders	1/162	0/162
FatigueGeneral disorders	1/162	0/162
Neck PainMusculoskeletal and connective tissue disorders	1/162	0/162
Urinary Tract InfectionInfections and infestations	0/162	1/162
Gastrointestinal intoleranceGastrointestinal disorders	0/162	1/162
Urinary frequencyGeneral disorders	1/162	0/162

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Dapagliflozin	Placebo	Total
Median	69 (64 to 77)	71 (63 to 78)	70 (63 to 77)

Sex: Female, Male
Sex: Female, Male(Participants)	Dapagliflozin	Placebo	Total
Female	92	92	184
Male	70	70	140

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Dapagliflozin	Placebo	Total
American Indian or Alaska Native	0	1	1
Asian	3	0	3
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	50	47	97
White	108	107	215
More than one race	0	2	2
Unknown or Not Reported	1	4	5

Region of Enrollment
Region of Enrollment(participants)	Dapagliflozin	Placebo	Total
United States	162	162	324

Duration of Heart Failure
Duration of Heart Failure(years)	Dapagliflozin	Placebo	Total
Median	3.0 (1.1 to 6.5)	3.2 (1.0 to 6.6)	3.0 (1.0 to 6.5)

Previous Hospitalization for Heart Failure
Previous Hospitalization for Heart Failure(Participants)	Dapagliflozin	Placebo	Total
Count of participants	98	83	181

Ejection Fraction
Ejection Fraction(percent)	Dapagliflozin	Placebo	Total
Median	60 (55 to 65)	60 (54 to 65)	60 (55 to 65)

Ischemic Heart Disease
Ischemic Heart Disease(Participants)	Dapagliflozin	Placebo	Total
Count of participants	32	31	63

29 further baseline measures are reported on the registry.

Study locations

26 sites

Heart Group of the Eastern Shore
Fairhope, Alabama 36532, United States
University of Southern California
Los Angeles, California 90032, United States
First Coast Cardiovascular Institute
Jacksonville, Florida 32256, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida 33952, United States
Emory University
Atlanta, Georgia 30303, United States
NorthShore University HealthSystem Research Insititute
Evanston, Illinois 60201, United States
Northwestern University
Evanston, Illinois 60208, United States
Chicago Medical Research
Hazel Crest, Illinois 60429, United States
OSF HealthCare Cardiovascular Institute
Peoria, Illinois 61606, United States
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana 46260, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas 66606, United States
Johns Hopkins University
Baltimore, Maryland 21205, United States
Massachusetts Hospital
Boston, Massachusetts 02114, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
Saint Luke's Mid America Heart Institute
Kansas City, Missouri 64111, United States
Washington University
Saint Louis, Missouri 63110, United States
Columbia University
New York, New York 10032, United States
St. Francis Hospital
New York, New York 11576, United States
Eastern Nephrology Associates
New Bern, North Carolina 28562, United States
Wake Forest University
Winston-Salem, North Carolina 27157, United States
Oregon Health and Science University
Portland, Oregon 97239, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania 15212, United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232, United States
Baylor Scott and White Research Institute
Dallas, Texas 75204, United States
University of Utah
Salt Lake City, Utah 84112, United States
Eastern Virginia Medical School
Norfolk, Virginia 23501, United States

References and documents

Publications

Nassif ME, Windsor SL, Borlaug BA, Kitzman DW, Shah SJ, Tang F, Khariton Y, Malik AO, Khumri T, Umpierrez G, Lamba S, Sharma K, Khan SS, Chandra L, Gordon RA, Ryan JJ, Chaudhry SP, Joseph SM, Chow CH, Kanwar MK, Pursley M, Siraj ES, Lewis GD, Clemson BS, Fong M, Kosiborod MN. The SGLT2 inhibitor dapagliflozin in heart failure with preserved ejection fraction: a multicenter randomized trial. Nat Med. 2021 Nov;27(11):1954-1960. doi: 10.1038/s41591-021-01536-x. Epub 2021 Oct 28. PubMed 34711976 ↗
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. PubMed 31081589 ↗

Study documents

Study protocol · Mar 20, 2020
Statistical analysis plan · Aug 12, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03030235
Lead sponsor: Saint Luke's Health System
Responsible party: Sponsor
First posted: Jan 24, 2017
Start date: Mar 1, 2017
Primary completion: Aug 13, 2021
Completion: Aug 13, 2021
Results posted: Oct 19, 2022
Last update: Oct 19, 2022

Study contacts

Mikhail Kosiborod, MD

study chair · Saint Luke's Mid America Heart Institute

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

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Other studies from this sponsor

Saint Luke's Health System

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