Effect of Dapagliflozin at Discharge on Hospital Re-Admissions in Patients With Acutely Decompensated Heart Failure: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Dapagliflozin (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death
时间窗: Up to 26 weeks
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.
次要结局
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Score(Baseline, Week 12, Week 26)
- Weight(Baseline,Week 12, Week 26)
- Systolic Blood Pressure(Baseline, Week 12, Week 26)
- Number of Participants With Stroke(Up to Week 26)
- N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels(Baseline, Week 12, Week 26)
- Hemoglobin A1C (HbA1c) Level(Baseline, Week 12, Week 26)
- Left Atrial Diameter(Baseline, Week 12, Week 26)
- Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score(Baseline, Week 12, Week 26)
- 6-Minute Walk Distance (6MWD)(Baseline, Week 12, Week 26)
- Number of Participants With Non-fatal Myocardial Infarction (MI)(Up to Week 26)
- Number of Participants With Acute Kidney Injury(Up to Week 26)
- Serum Magnesium(Baseline, Week 12, Week 26)
- Number of Participants Dying From Cardiovascular Reasons(Up to Week 26)
研究者
Guillermo Umpierrez
Professor
Emory University