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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
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.
Participants will receive a placebo to match 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.
Emory University Hospital
Atlanta, Georgia, United States
Tulane University
New Orleans, Louisiana, United States
Temple University
Philadelphia, Pennsylvania, United States
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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