CompletedNCT04249778Updated Jun 14, 2024Results posted

Dapagliflozin at Discharge on Hospital Heart Failure Readmission

A Phase 4 interventional study of Dapagliflozin and Placebo in Heart Failure and Diabetes, sponsored by Emory University. Completed at 3 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Emory University · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 105
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study summary

This study will evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, emergency room (ER) visits, urgent clinic visits, and death in patients with and without type 2 diabetes (T2D) after hospital admission for heart failure.

Read the detailed description

The prevalence of both heart failure and type 2 diabetes (T2D) or prediabetes are reaching epidemic proportions globally and in the United States. More than 40% of patients with established heart failure (HF) have diabetes.

Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor (SGLT2-i) indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus. Treatment with SGLT2-i has been shown to reduce both heart failure hospitalizations and mortality in patients with established heart disease. However, the time of initiation of SGLT2-i therapy has not been evaluated in patients with HF. This study will be the first trial to evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, ER visits, urgent clinic visits, and death in patients with and without T2D after hospital admission for heart failure. In addition, the impact of treatment on HF symptoms quality of life, resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be evaluated. The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of patients with heart failure.

Patients with and without diabetes who have acute decompensated heart failure (ADHF) will be randomized to take either dapagliflozin or placebo daily for 26 weeks, beginning at the time of discharge from from the hospital.

Conditions studied

Heart Failure
Diabetes

Browse trials for

Heart Failure 5,701

Keywords

hospitalization
mortality
time of initiation of therapy
quality of life
cost-effectiveness
dapagliflozin
clinical trial
diabetes

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 105 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

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

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males or females between the ages of 18 and 90 years, with ADHF, and New York Heart Association (NYHA) class II, III, or IV symptoms discharged after hospital admission with a clinical diagnosis ADHF
Elevated natriuretic peptide tests measure levels of BNP (NT-pro-BNP) ≥300 pg/ml or B-type natriuretic peptide (BNP) ≥100 pg/ml on admission
Interpretable echocardiogram during hospital admission (or within 12 months prior to index hospitalization)
Blood glucose level \<400 mg/dL without evidence of diabetic ketoacidosis (serum bicarbonate \<18 milliequivalent (mEq)/L or positive serum or urinary ketones), in patients with T2D

Exclusion criteria

Exclusion Criteria:

Age \< 18 or > 90 years
Subjects with a history of type 1 diabetes
Treatment with thiazolidinediones (TZDs) or SGLT2-i during the past 3 months of admission
Recurrent episodes of severe hypoglycemia or hypoglycemic unawareness
History of recurrent HF admissions considered to be due to non-compliance (evaluated by the research staff for participation)
Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 times upper limit of normal
Patients with impaired renal function (GFR \< 25 ml/min)
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Patients on ventricular assist devices (VADs)
History of heart transplant or listed for heart transplant
History of cardiac surgery (within 90 days prior to enrollment) or planned cardiac interventions within the following 6 months, including percutaneous coronary intervention (PCI), ablation, cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator (ICD)
HF due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valvular diseases, hypertrophic cardiomyopathy, or congenital heart disease
History of SGLT2-i allergy
Systolic blood pressure \< 100 mmHg
Uncontrolled hypertension, defined as a systolic blood pressure > 200 mmHg at randomization
Female subjects who are pregnant or breast-feeding at time of enrollment into the study
Females of childbearing potential who are not using adequate contraceptive methods
In hospice or expected life expectancy less than 6 months
Patients with diabetic foot infection, osteomyelitis and history of amputation of lower extremities within 6 months of admission
Patients anticipated to undergo major surgical procedures during the following 6 months
Patients with active hematuria, urinary tract infection (UTI), or history of frequent UTIs or genital mycotic infections
Uncontrolled atrial fibrillation or atrial flutter with a resting heart rate >110bpm documented by ECG at randomization
Any condition that in the opinion of the investigator would contraindicate the assessment of distance walked in 6 minutes (6MWD)
Chronic pulmonary disease, i.e. with known forced expiratory volume in the first second (FEV1) \<50% requiring home oxygen, or oral steroid therapy or current hospitalization for severe chronic obstructive pulmonary disease (COPD) thought to be a primary contributor to dyspnea, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
Patients with active history of bladder cancer
Patients with previous history of diabetic ketoacidosis, per American Diabetes Association (ADA) criteria

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 105 participants (actual)

Study arms

Experimental
Dapagliflozin
Patients admitted with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily for 26 weeks.
Drug: Dapagliflozin
Placebo comparator
Placebo
Patients admitted with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily for 26 weeks.
Drug: Placebo

Interventions

DrugDapagliflozin
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Participants will receive 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.
Also known as: FARXIGA
DrugPlacebo
Participants will receive a placebo to match 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.

What researchers measure

Primary outcomes

Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death
The number of participants meeting criteria for a composite of hospital admissions, emergency department visits, urgent clinic visits for heart failure and death after admission with acute decompensated heart failure (ADHF) was determined.
Time frame: Up to 26 weeks

Secondary outcomes

Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline, Week 12, Week 26
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) assesses patients' perception of their heart failure and measures the impact of heart failure symptoms. The CHQ-SAS contains 16 standardized questions that assess dyspnea during daily activities, fatigue and emotional function. Items are rated on a 7-point Likert scale ranging from 1 to 7. The total score is the mean of the item scores and higher scores indicate better quality of life.
Time frame: Baseline, Week 12, Week 26
N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
The heart failure, disease-specific biomarker N-terminal (NT)-pro hormone BNP (NT-proBNP) is a non-active prohormone. Levels increase when heart failure develops or gets worse and levels reduce when heart failure is stable.
Time frame: Baseline, Week 12, Week 26
6-Minute Walk Distance (6MWD)
The 6-Minute Walk Distance (6MWD) test measures the distance, in meters, that a patient can quickly walk on a flat, hard surface in a period of 6 minutes
Time frame: Baseline, Week 12, Week 26
Hemoglobin A1C (HbA1c) Level
HbA1c was quantified by blood test, in participants with type 2 diabetes (T2D). Higher percentages of glycated hemoglobin on red blood cells (RBCs) indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.
Time frame: Baseline, Week 12, Week 26
Weight
Weight is measured in kilograms.
Time frame: Baseline,Week 12, Week 26
Systolic Blood Pressure
Systolic blood pressure is measured in millimeters of mercury (mmHg). A normal systolic blood pressure level is less than 120 mmHg.
Time frame: Baseline, Week 12, Week 26
Left Atrial Diameter
The normal range for left atrial diameter is 2.0 to 4.0 centimeters (cm). The left atrium increases in size with heart conditions.
Time frame: Baseline, Week 12, Week 26
Serum Magnesium
Normal levels of serum magnesium are between 1.7 and 2.3 milligrams per deciliter (mg/dL).
Time frame: Baseline, Week 12, Week 26
Number of Participants Dying From Cardiovascular Reasons
The number of participants dying due to cardiovascular reasons was documented.
Time frame: Up to Week 26
Number of Participants With Non-fatal Myocardial Infarction (MI)
The number of participants with non-fatal myocardial infarction (MI) was documented.
Time frame: Up to Week 26
Number of Participants With Stroke
The number of participants experiencing a stroke was documented.
Time frame: Up to Week 26
Number of Participants With Acute Kidney Injury
The number of participants experiencing acute kidney injury was documented.
Time frame: Up to Week 26

Results

Posted Mar 29, 2023

Limitations and caveats

This study occurred during the Coronavirus Disease 2019 (COVID-19) pandemic resulting in many participants lost to follow-up.

Participant flow

Participants were recruited from three sites in the USA: Emory University Hospital in Atlanta, Georgia, Tulane University in New Orleans, Louisiana, and Temple University in Philadelphia, Pennsylvania. Participant enrollment began July 29, 2020 and all follow-up assessments were completed by March 3, 2022.

Participant flow — Overall Study
Milestone	Dapagliflozin	Placebo
Started	50	55
Started study medication	46	53
Attended week 12 visit	16	19
Completed	15	12
Not completed	35	43

Outcome measures

PrimaryNumber of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death

The number of participants meeting criteria for a composite of hospital admissions, emergency department visits, urgent clinic visits for heart failure and death after admission with acute decompensated heart failure (ADHF) was determined.

Time frame:: Up to 26 weeks
Reported as:: Count of participants · Participants

Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death
Participants	Dapagliflozin	Placebo
Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death	0	3

SecondaryKansas City Cardiomyopathy Questionnaire (KCCQ) Score

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Time frame:: Baseline, Week 12, Week 26
Reported as:: Mean · score on a scale

Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
score on a scale	Dapagliflozin	Placebo
Baseline	55.72 ± 23.23	50.71 ± 25.10
Week 12	62.40 ± 37.52	66.95 ± 36.93
Week 26	83.36 ± 13.51	80.38 ± 17.46

SecondaryChronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score

Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) assesses patients' perception of their heart failure and measures the impact of heart failure symptoms. The CHQ-SAS contains 16 standardized questions that assess dyspnea during daily activities, fatigue and emotional function. Items are rated on a 7-point Likert scale ranging from 1 to 7. The total score is the mean of the item scores and higher scores indicate better quality of life.

Time frame:: Baseline, Week 12, Week 26
Reported as:: Mean · score on a scale

Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
score on a scale	Dapagliflozin	Placebo
Baseline	4.04 ± 1.51	4.07 ± 1.31
Week 12	5.25 ± 1.05	5.34 ± 1.14
Week 26	5.27 ± 0.93	5.27 ± 1.17

SecondaryN-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels

The heart failure, disease-specific biomarker N-terminal (NT)-pro hormone BNP (NT-proBNP) is a non-active prohormone. Levels increase when heart failure develops or gets worse and levels reduce when heart failure is stable.

Time frame:: Baseline, Week 12, Week 26
Reported as:: Mean · picograms per milliliter (pg/mL)

N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
picograms per milliliter (pg/mL)	Dapagliflozin	Placebo
Baseline	1947.38 ± 2641.03	1469.86 ± 1713.87
Week 12	589.25 ± 391.37	1083.00 ± 1554.99
Week 26	674.50 ± 388.71	730.00 ± 541.06

Secondary6-Minute Walk Distance (6MWD)

The 6-Minute Walk Distance (6MWD) test measures the distance, in meters, that a patient can quickly walk on a flat, hard surface in a period of 6 minutes

Time frame:: Baseline, Week 12, Week 26
Reported as:: Mean · meters (m)

6-Minute Walk Distance (6MWD)
meters (m)	Dapagliflozin	Placebo
Baseline	893.42 ± 394.61	1109.05 ± 1271.43
Week 12	1185.76 ± 321.27	1548.23 ± 1807.13
Week 26	995.23 ± 414.59	1123.19 ± 379.64

SecondaryHemoglobin A1C (HbA1c) Level

HbA1c was quantified by blood test, in participants with type 2 diabetes (T2D). Higher percentages of glycated hemoglobin on red blood cells (RBCs) indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.

Time frame:: Baseline, Week 12, Week 26
Reported as:: Mean · percent of RBCs with glycated hemoglobin

Hemoglobin A1C (HbA1c) Level
percent of RBCs with glycated hemoglobin	Dapagliflozin	Placebo
Baseline	9.41 ± 2.33	8.98 ± 1.91
Week 12	8.62 ± 2.12	8.47 ± 2.88
Week 26	9.47 ± 2.84	7.84 ± 2.38

SecondaryWeight

Weight is measured in kilograms.

Time frame:: Baseline,Week 12, Week 26
Reported as:: Mean · kilograms

Weight
kilograms	Dapagliflozin	Placebo
Baseline	101.21 ± 35.77	103.59 ± 27.77
Week 12	95.93 ± 30.26	101.18 ± 20.53
Week 26	98.06 ± 29.05	100.18 ± 18.55

SecondarySystolic Blood Pressure

Systolic blood pressure is measured in millimeters of mercury (mmHg). A normal systolic blood pressure level is less than 120 mmHg.

Time frame:: Baseline, Week 12, Week 26
Reported as:: Mean · mmHg

Systolic Blood Pressure
mmHg	Dapagliflozin	Placebo
Baseline	124.39 ± 14.51	125.36 ± 17.38
Week 12	118.15 ± 21.57	124.31 ± 19.88
Week 26	131.69 ± 21.76	136.79 ± 23.69

SecondaryLeft Atrial Diameter

The normal range for left atrial diameter is 2.0 to 4.0 centimeters (cm). The left atrium increases in size with heart conditions.

Time frame:: Baseline, Week 12, Week 26
Reported as:: Mean · centimeters

Left Atrial Diameter
centimeters	Dapagliflozin	Placebo
Baseline	4.47 ± 0.79	4.32 ± 0.75
Week 12	4.55 ± 0.82	4.91 ± 0.43
Week 26	4.30 ± 1.12	4.31 ± 0.72

SecondarySerum Magnesium

Normal levels of serum magnesium are between 1.7 and 2.3 milligrams per deciliter (mg/dL).

Time frame:: Baseline, Week 12, Week 26
Reported as:: Mean · mg/dL

Serum Magnesium
mg/dL	Dapagliflozin	Placebo
Baseline	2.01 ± 0.27	1.92 ± 0.48
Week 12	2.11 ± 0.22	2.02 ± 0.23
Week 26	2.13 ± 0.17	1.98 ± 0.27

SecondaryNumber of Participants Dying From Cardiovascular Reasons

The number of participants dying due to cardiovascular reasons was documented.

Time frame:: Up to Week 26
Reported as:: Count of participants · Participants

Number of Participants Dying From Cardiovascular Reasons
Participants	Dapagliflozin	Placebo
Number of Participants Dying From Cardiovascular Reasons	0	0

SecondaryNumber of Participants With Non-fatal Myocardial Infarction (MI)

The number of participants with non-fatal myocardial infarction (MI) was documented.

Time frame:: Up to Week 26
Reported as:: Count of participants · Participants

Number of Participants With Non-fatal Myocardial Infarction (MI)
Participants	Dapagliflozin	Placebo
Number of Participants With Non-fatal Myocardial Infarction (MI)	0	0

SecondaryNumber of Participants With Stroke

The number of participants experiencing a stroke was documented.

Time frame:: Up to Week 26
Reported as:: Count of participants · Participants

Number of Participants With Stroke
Participants	Dapagliflozin	Placebo
Number of Participants With Stroke	1	0

SecondaryNumber of Participants With Acute Kidney Injury

The number of participants experiencing acute kidney injury was documented.

Time frame:: Up to Week 26
Reported as:: Count of participants · Participants

Number of Participants With Acute Kidney Injury
Participants	Dapagliflozin	Placebo
Number of Participants With Acute Kidney Injury	0	0

Adverse events

Collected over Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the Week 26 study visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dapagliflozin	0/50 (0%)	3/50 (6%)	4/50 (8%)
Placebo	0/55 (0%)	5/55 (9.1%)	2/55 (3.6%)

Most frequent serious events

Most frequent serious events
Event	Dapagliflozin	Placebo
Hospital readmission due to heart failure exacerbationCardiac disorders	0/50	3/55
Hospital readmission due to pneumoniaInfections and infestations	1/50	0/55
Hospital readmission due to gastroparesisGastrointestinal disorders	1/50	0/55
Hospital readmission due to cerebrovascular accident (CVA)Vascular disorders	1/50	0/55
Hospital readmission due to fall/weaknessGeneral disorders	0/50	1/55
Hospital readmission due to chronic obstructive pulmonary disease (COPD) exacerbationRespiratory, thoracic and mediastinal disorders	0/50	1/55

Most frequent other events

Most frequent other events
Event	Dapagliflozin	Placebo
Yeast infectionInfections and infestations	1/50	0/55
Peeling dry skinSkin and subcutaneous tissue disorders	1/50	0/55
Elective mitral valve replacementSurgical and medical procedures	1/50	0/55
Gout arthritisMusculoskeletal and connective tissue disorders	1/50	0/55
COVID-19Infections and infestations	0/50	1/55
ICD ImplantSurgical and medical procedures	0/50	1/55

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Dapagliflozin	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	40	45	85
>=65 years	10	10	20

Age, Continuous
Age, Continuous(years)	Dapagliflozin	Placebo	Total
Mean	56.12 ± 13.47	55.49 ± 11.63	55.79 ± 12.48

Sex: Female, Male
Sex: Female, Male(Participants)	Dapagliflozin	Placebo	Total
Female	30	10	40
Male	20	45	65

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Dapagliflozin	Placebo	Total
Hispanic or Latino	2	0	2
Not Hispanic or Latino	48	55	103
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Dapagliflozin	Placebo	Total
American Indian or Alaska Native	4	5	9
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	38	42	80
White	8	8	16
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Dapagliflozin	Placebo	Total
United States	50	55	105

Diabetes Status
Diabetes Status(Participants)	Dapagliflozin	Placebo	Total
Diabetic (Type 2 Diabetes)	21	17	38
Non-diabetic	26	31	57
Pre-diabetic	3	7	10

Study locations

3 sites

Emory University Hospital
Atlanta, Georgia 30322, United States
Tulane University
New Orleans, Louisiana 70118, United States
Temple University
Philadelphia, Pennsylvania 19122, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jul 6, 2021

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

Individual participant data

Plan to share: Yes — Individual participant data that underlie results reported, will be available for sharing after de-identification, including text, tables, figures, and appendices.

Supporting information: Study protocol

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04249778
Lead sponsor: Emory University
Responsible party: Guillermo Umpierrez (Professor, Emory University) — Principal investigator
First posted: Jan 31, 2020
Start date: Jul 29, 2020
Primary completion: Mar 3, 2022
Completion: Mar 3, 2022
Results posted: Mar 29, 2023
Last update: Jun 14, 2024

Study contacts

Guillermo Umpierrez, MD

principal investigator · Emory University

Oversight

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

View the source record on ClinicalTrials.gov ↗

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