RECRUITING

Effects of Acute and Chronic Empagliflozin Heart Failure

Conditions

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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

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.

Official Title

Renal Mechanistic Effects of Acute and Chronic Empagliflozin in Heart Failure

Quick Facts

Study Start:2023-08-04

Study Completion:2024-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05553938

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 Criteria	Exclusion Criteria
* 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	* Need for heart failure hospitalization at the time of randomization * Current use or plan to initiate renal replacement therapy * 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) * Critical stenotic valvular disease, complex congenital heart disease or prior heart transplant * 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 * Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study) or active bleeding * Pregnancy or breastfeeding * 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)

Inclusion Criteria

Exclusion Criteria

* 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

* Need for heart failure hospitalization at the time of randomization
* Current use or plan to initiate renal replacement therapy
* 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)
* Critical stenotic valvular disease, complex congenital heart disease or prior heart transplant
* 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
* Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study) or active bleeding
* Pregnancy or breastfeeding
* 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)

Contacts and Locations

Study Contact

Veena Rao, PHD

CONTACT

2037373571

veena.s.rao@yale.edu

Kara Otis

CONTACT

2037373571

kara.otis@yale.edu

Principal Investigator

Jeffrey Testani, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale New Haven Hospital

New Haven, Connecticut, 06520

United States

Yale University

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Jeffrey Testani, MD, PRINCIPAL_INVESTIGATOR, 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 Date2023-08-04

Study Completion Date2024-11

Study Record Updates

Study Start Date2023-08-04

Study Completion Date2024-11

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure