NCT05553938Active, not recruitingPhase 1
Effects of Acute and Chronic Empagliflozin Heart Failure
Renal Mechanistic Effects of Acute and Chronic Empagliflozin in Heart Failure
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 21 Sept 2022
- Start date
- 4 Aug 2023
- Primary completion date
- 8 May 2026
- Lead sponsor
- Yale University
- Diseases
- Heart failure
- NCT number
- NCT05553938
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 60
- From 4 Aug 2023 to the primary completion date, 8 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use or plan to initiate renal replacement therapy
- Critical stenotic valvular disease, complex congenital heart disease or prior heart transplant
Other illness
- Need for heart failure hospitalization at the time of randomization
- History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
- History of or current urosepsis or frequent urinary tract infections
- Appears unlikely or unable to participate in the required study procedures, as assessed by the study PI, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease)
Lab values
- Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study) or active bleeding
Other
- Significant bladder dysfunction or urinary incontinence
- Inability to comply with the serial urine collection procedures
- Chronic use of natriuretic doses of thiazide diuretics (≥50mg hydrochlorothiazide or equivalent)
- Pregnancy or breastfeeding
Who the study is looking for
- A clinical diagnosis of worsening heart failure (worsening of congestive symptoms with current therapies) in the opinion of the investigator.
- A planned outpatient diuretic intervention (either up-titration of loop or addition of thiazide diuretic) for worsening heart failure per treating clinician. Diuretic intervention can occur via an unplanned in person visit (e.g., outpatient ambulatory clinic, emergency department, same day access visit) or via a telephone encounter (e.g., patient calling the clinic with reported weight gain and SOB that is prescribed uptitration of diuretic therapy).
- Estimated or reported weight gain of at least 5 lbs.
- Chronic daily oral loop diuretic dose ≥ 20mg furosemide equivalents for at least one month prior to enrollment
- Estimated GFR (eGFR) ≥ 20 mL/min/1.73 m2
- Age ≥ 18 years old
- Signed informed consent
- English speaking participants only
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.