Actively Recruiting
Effects of Acute and Chronic Empagliflozin Heart Failure
Led by Yale University · Updated on 2024-12-18
60
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 60-patient randomized, double-blind, placebo-controlled mechanistic study to understand the utility of empagliflozin in worsening heart failure (HF) patients with or without diabetes. Participants will be randomized to empagliflozin or placebo for 6 weeks, followed by a crossover of placebo patients to active therapy at 6 weeks-12 weeks.
CONDITIONS
Official Title
Effects of Acute and Chronic Empagliflozin Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of worsening heart failure with worsening congestive symptoms
- Planned outpatient increase or addition of diuretic therapy for worsening heart failure
- Estimated or reported weight gain of at least 5 pounds
- Daily oral loop diuretic dose of 20 mg furosemide equivalent or higher for at least one month
- Estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73 m2 or greater
- Age 18 years or older
- Signed informed consent
- English-speaking participants only
You will not qualify if you...
- Need for hospitalization for heart failure at the time of randomization
- Current use or planned start of renal replacement therapy
- Significant bladder problems or urinary incontinence
- Unable to comply with required urine collection procedures
- Chronic use of high-dose thiazide diuretics (50 mg hydrochlorothiazide or equivalent)
- Critical valvular heart disease, complex congenital heart disease, or prior heart transplant
- History of type 1 diabetes, diabetic ketoacidosis, brittle diabetes, or severe hypoglycemia requiring emergency care in the last 6 months
- History or current urosepsis or frequent urinary tract infections
- Anemia with hemoglobin below 8 g/dL or active bleeding
- Pregnancy or breastfeeding
- Unlikely or unable to participate due to psychiatric, addictive, or neurological conditions as assessed by study staff
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
V
Veena Rao, PHD
CONTACT
K
Kara Otis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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