RECRUITING

Ertugliflozin in Chronic Heart Failure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ertugliflozin in Chronic Heart Failure: Cardio-renal and Diuretic Effects

Quick Facts

Study Start:2021-03-10
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04438213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. A clinical diagnosis of ADHF with at least one objective sign of volume overload (rales, edema, elevated JVP, or preadmission weight gain)
  2. 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. 3. Chronic daily oral loop diuretic dose \> or equal to 20mg furosemide equivalents for at least one month prior to admission
  4. 4. eGFR 30 mL/min/1.73 m2
  5. 5. Signed informed consent
  1. 1. Current use or plan to initiate renal replacement therapy or ultrafiltration this hospital admission
  2. 2. Significant bladder dysfunction or urinary incontinence
  3. 3. Inability to comply with the serial urine collection procedures
  4. 4. Current use of a thiazide or thiazide like diuretics or use within 5 half-lives of the drug, including metolazone
  5. 5. Prior heart transplant, critical stenotic valvular disease or complex congenital heart
  6. 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. 7. History of or current urosepsis or frequent urinary tract infections
  8. 8. Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study)
  9. 9. Pregnancy or breastfeeding

Contacts and Locations

Study Contact

Veena Rao, PHD
CONTACT
(203) 737-3571
veena.s.rao@yale.edu
Kara Otis
CONTACT
(203) 785-7917
kara.otis@yale.edu

Study Locations (Sites)

Yale School of Medicine
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

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

Study Start Date2021-03-10
Study Completion Date2025-07

Study Record Updates

Study Start Date2021-03-10
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Ertugliflozin
  • Metolazone

Additional Relevant MeSH Terms

  • Heart Failure