Ertugliflozin in Chronic Heart Failure
The purpose of this study is to determine the effects on heart failure signs and symptoms of the use of either ertugliflozin, metolazone or placebo, in conjunction with intravenous loop diuretic use in acute settings and chronic oral loop diuretic therapy. There are two general purposes for this study. The proposed study is both larger and more rigorous than essentially all PK/PD studies that form the basis of current practice with loop diuretics as well as all studies looking at add-on thiazide therapy (current guideline-recommended adjuvant). The second is to generate a mechanistic understanding of the pleotropic cardio-renal factors with chronic therapy that differentiate ertugliflozin from traditional diuretics particularly in how they maintain reduced blood volume without the complication of over-diuresis and volume depletion.
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 10 March 2021
🗓️ Primary Completion (Estimated) 31 January 2025
✅ Study Completion (Estimated) July 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 New Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. A clinical diagnosis of ADHF with at least one objective sign of volume overload (rales, edema, elevated JVP, or preadmission weight gain)
    • 2. As judged by the treating physician, a projected need and ability to tolerate treatment with an extended need for IV diuretics with the goal of significant fluid removal (i.e., goal \>1L/day net fluid loss)
    • 3. Chronic daily oral loop diuretic dose \> or equal to 20mg furosemide equivalents for at least one month prior to admission
    • 4. eGFR 30 mL/min/1.73 m2
    • 5. Signed informed consent

    Exclusion Criteria:

    • 1. Current use or plan to initiate renal replacement therapy or ultrafiltration this hospital admission
    • 2. Significant bladder dysfunction or urinary incontinence
    • 3. Inability to comply with the serial urine collection procedures
    • 4. Current use of a thiazide or thiazide like diuretics or use within 5 half-lives of the drug, including metolazone
    • 5. Prior heart transplant, critical stenotic valvular disease or complex congenital heart
    • 6. 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 3 months
    • 7. History of or current urosepsis or frequent urinary tract infections
    • 8. Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study)
    • 9. Pregnancy or breastfeeding
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 June 2020
  • First Submitted that Met QC Criteria 16 June 2020
  • First Posted 18 June 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 May 2024
  • Last Update Posted 3 May 2024
  • Last Verified May 2024