Phase 4
N=105
Dapagliflozin at Discharge on Hospital Heart Failure Readmission
Heart Failure · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04249778 ↗Enrolled (actual)
105
Serious AEs
7.6%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death — 0; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dapagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death |
0; 3 | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire (KCCQ) Score |
55.72; 50.71; 62.40; 66.95; 83.36; 80.38 | — |
| SECONDARY Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score |
4.04; 4.07; 5.25; 5.34; 5.27; 5.27 | — |
| SECONDARY N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels |
1947.38; 1469.86; 589.25; 1083.00; 674.50; 730.00 | — |
| SECONDARY 6-Minute Walk Distance (6MWD) |
893.42; 1109.05; 1185.76; 1548.23; 995.23; 1123.19 | — |
| SECONDARY Hemoglobin A1C (HbA1c) Level |
9.41; 8.98; 8.62; 8.47; 9.47; 7.84 | — |
| SECONDARY Weight |
101.21; 103.59; 95.93; 101.18; 98.06; 100.18 | — |
| SECONDARY Systolic Blood Pressure |
124.39; 125.36; 118.15; 124.31; 131.69; 136.79 | — |
| SECONDARY Left Atrial Diameter |
4.47; 4.32; 4.55; 4.91; 4.30; 4.31 | — |
| SECONDARY Serum Magnesium |
2.01; 1.92; 2.11; 2.02; 2.13; 1.98 | — |
| SECONDARY Number of Participants Dying From Cardiovascular Reasons |
0; 0 | — |
| SECONDARY Number of Participants With Non-fatal Myocardial Infarction (MI) |
0; 0 | — |
| SECONDARY Number of Participants With Stroke |
1; 0 | — |
| SECONDARY Number of Participants With Acute Kidney Injury |
0; 0 | — |
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.
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT04249778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.