Trial Outcomes & Findings for Dapagliflozin at Discharge on Hospital Heart Failure Readmission (NCT NCT04249778)
NCT ID: NCT04249778
Last Updated: 2024-06-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
Up to 26 weeks
Results posted on
2024-06-14
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 milestones
| Measure |
Dapagliflozin
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
55
|
|
Overall Study
Started Study Medication
|
46
|
53
|
|
Overall Study
Attended Week 12 Visit
|
16
|
19
|
|
Overall Study
COMPLETED
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
35
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dapagliflozin at Discharge on Hospital Heart Failure Readmission
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=50 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=55 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Continuous
|
56.12 years
STANDARD_DEVIATION 13.47 • n=99 Participants
|
55.49 years
STANDARD_DEVIATION 11.63 • n=107 Participants
|
55.79 years
STANDARD_DEVIATION 12.48 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Diabetes Status
Diabetic (Type 2 Diabetes)
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Diabetes Status
Non-diabetic
|
26 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Diabetes Status
Pre-diabetic
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: This analysis includes participants who started the study drug.
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.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: This analysis includes participants who started the study drug and attended the indicated study visits.
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.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Week 26
|
83.36 score on a scale
Standard Deviation 13.51
|
80.38 score on a scale
Standard Deviation 17.46
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Baseline
|
55.72 score on a scale
Standard Deviation 23.23
|
50.71 score on a scale
Standard Deviation 25.10
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Week 12
|
62.40 score on a scale
Standard Deviation 37.52
|
66.95 score on a scale
Standard Deviation 36.93
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: This analysis includes participants who started the study drug and attended the indicated study visits.
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.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
Baseline
|
4.04 score on a scale
Standard Deviation 1.51
|
4.07 score on a scale
Standard Deviation 1.31
|
|
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
Week 12
|
5.25 score on a scale
Standard Deviation 1.05
|
5.34 score on a scale
Standard Deviation 1.14
|
|
Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
Week 26
|
5.27 score on a scale
Standard Deviation 0.93
|
5.27 score on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: This analysis includes participants who started the study drug and attended the indicated study visits.
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.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
Week 26
|
674.50 picograms per milliliter (pg/mL)
Standard Deviation 388.71
|
730.00 picograms per milliliter (pg/mL)
Standard Deviation 541.06
|
|
N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
Baseline
|
1947.38 picograms per milliliter (pg/mL)
Standard Deviation 2641.03
|
1469.86 picograms per milliliter (pg/mL)
Standard Deviation 1713.87
|
|
N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
Week 12
|
589.25 picograms per milliliter (pg/mL)
Standard Deviation 391.37
|
1083.00 picograms per milliliter (pg/mL)
Standard Deviation 1554.99
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: This analysis includes participants who started the study drug and who were physically able to partake in this assessment at the indicated study visits.
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
Outcome measures
| Measure |
Dapagliflozin
n=29 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=28 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
6-Minute Walk Distance (6MWD)
Baseline
|
893.42 meters (m)
Standard Deviation 394.61
|
1109.05 meters (m)
Standard Deviation 1271.43
|
|
6-Minute Walk Distance (6MWD)
Week 12
|
1185.76 meters (m)
Standard Deviation 321.27
|
1548.23 meters (m)
Standard Deviation 1807.13
|
|
6-Minute Walk Distance (6MWD)
Week 26
|
995.23 meters (m)
Standard Deviation 414.59
|
1123.19 meters (m)
Standard Deviation 379.64
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: This analysis includes participants with type 2 diabetes who started the study drug and attended the indicated study visits.
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.
Outcome measures
| Measure |
Dapagliflozin
n=21 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=17 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Hemoglobin A1C (HbA1c) Level
Week 26
|
9.47 percent of RBCs with glycated hemoglobin
Standard Deviation 2.84
|
7.84 percent of RBCs with glycated hemoglobin
Standard Deviation 2.38
|
|
Hemoglobin A1C (HbA1c) Level
Baseline
|
9.41 percent of RBCs with glycated hemoglobin
Standard Deviation 2.33
|
8.98 percent of RBCs with glycated hemoglobin
Standard Deviation 1.91
|
|
Hemoglobin A1C (HbA1c) Level
Week 12
|
8.62 percent of RBCs with glycated hemoglobin
Standard Deviation 2.12
|
8.47 percent of RBCs with glycated hemoglobin
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: Baseline,Week 12, Week 26Population: This analysis includes participants who started the study drug and attended the indicated study visits.
Weight is measured in kilograms.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Weight
Baseline
|
101.21 kilograms
Standard Deviation 35.77
|
103.59 kilograms
Standard Deviation 27.77
|
|
Weight
Week 12
|
95.93 kilograms
Standard Deviation 30.26
|
101.18 kilograms
Standard Deviation 20.53
|
|
Weight
Week 26
|
98.06 kilograms
Standard Deviation 29.05
|
100.18 kilograms
Standard Deviation 18.55
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: This analysis includes participants who started the study drug and attended the indicated study visits.
Systolic blood pressure is measured in millimeters of mercury (mmHg). A normal systolic blood pressure level is less than 120 mmHg.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Systolic Blood Pressure
Baseline
|
124.39 mmHg
Standard Deviation 14.51
|
125.36 mmHg
Standard Deviation 17.38
|
|
Systolic Blood Pressure
Week 12
|
118.15 mmHg
Standard Deviation 21.57
|
124.31 mmHg
Standard Deviation 19.88
|
|
Systolic Blood Pressure
Week 26
|
131.69 mmHg
Standard Deviation 21.76
|
136.79 mmHg
Standard Deviation 23.69
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: This analysis includes participants who started the study drug and attended the indicated study visits.
The normal range for left atrial diameter is 2.0 to 4.0 centimeters (cm). The left atrium increases in size with heart conditions.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Left Atrial Diameter
Baseline
|
4.47 centimeters
Standard Deviation 0.79
|
4.32 centimeters
Standard Deviation 0.75
|
|
Left Atrial Diameter
Week 12
|
4.55 centimeters
Standard Deviation 0.82
|
4.91 centimeters
Standard Deviation 0.43
|
|
Left Atrial Diameter
Week 26
|
4.30 centimeters
Standard Deviation 1.12
|
4.31 centimeters
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Population: This analysis includes participants who started the study drug and attended the indicated study visits.
Normal levels of serum magnesium are between 1.7 and 2.3 milligrams per deciliter (mg/dL).
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Serum Magnesium
Week 26
|
2.13 mg/dL
Standard Deviation 0.17
|
1.98 mg/dL
Standard Deviation 0.27
|
|
Serum Magnesium
Baseline
|
2.01 mg/dL
Standard Deviation 0.27
|
1.92 mg/dL
Standard Deviation 0.48
|
|
Serum Magnesium
Week 12
|
2.11 mg/dL
Standard Deviation 0.22
|
2.02 mg/dL
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Up to Week 26Population: This analysis includes participants who started the study drug.
The number of participants dying due to cardiovascular reasons was documented.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Number of Participants Dying From Cardiovascular Reasons
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: This analysis includes participants who started the study drug.
The number of participants with non-fatal myocardial infarction (MI) was documented.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Number of Participants With Non-fatal Myocardial Infarction (MI)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: This analysis includes participants who started the study drug.
The number of participants experiencing a stroke was documented.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Number of Participants With Stroke
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: This analysis includes participants who started the study drug.
The number of participants experiencing acute kidney injury was documented.
Outcome measures
| Measure |
Dapagliflozin
n=46 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=53 Participants
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury
|
0 Participants
|
0 Participants
|
Adverse Events
Dapagliflozin
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin
n=50 participants at risk
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=55 participants at risk
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Cardiac disorders
Hospital readmission due to heart failure exacerbation
|
0.00%
0/50 • 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.
|
5.5%
3/55 • 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.
|
|
General disorders
Hospital readmission due to fall/weakness
|
0.00%
0/50 • 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.
|
1.8%
1/55 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hospital readmission due to chronic obstructive pulmonary disease (COPD) exacerbation
|
0.00%
0/50 • 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.
|
1.8%
1/55 • 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.
|
|
Infections and infestations
Hospital readmission due to pneumonia
|
2.0%
1/50 • 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.
|
0.00%
0/55 • 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.
|
|
Gastrointestinal disorders
Hospital readmission due to gastroparesis
|
2.0%
1/50 • 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.
|
0.00%
0/55 • 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.
|
|
Vascular disorders
Hospital readmission due to cerebrovascular accident (CVA)
|
2.0%
1/50 • 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.
|
0.00%
0/55 • 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.
|
Other adverse events
| Measure |
Dapagliflozin
n=50 participants at risk
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily.
|
Placebo
n=55 participants at risk
Patients admitted to the hospital with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily.
|
|---|---|---|
|
Infections and infestations
Yeast infection
|
2.0%
1/50 • 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.
|
0.00%
0/55 • 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.
|
|
Skin and subcutaneous tissue disorders
Peeling dry skin
|
2.0%
1/50 • 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.
|
0.00%
0/55 • 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.
|
|
Infections and infestations
COVID-19
|
0.00%
0/50 • 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.
|
1.8%
1/55 • Number of events 1 • 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.
|
|
Surgical and medical procedures
ICD Implant
|
0.00%
0/50 • 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.
|
1.8%
1/55 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Elective mitral valve replacement
|
2.0%
1/50 • Number of events 1 • 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.
|
0.00%
0/55 • 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.
|
|
Musculoskeletal and connective tissue disorders
Gout arthritis
|
2.0%
1/50 • Number of events 2 • 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.
|
0.00%
0/55 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place