RECRUITING

Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure

Conditions

Quick Navigation

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

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily. The purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.

Official Title

Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure

Quick Facts

Study Start:2024-09-15

Study Completion:2029-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06507657

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:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age \>60 years of age * Clinical diagnosis of hypertension * Body mass index ≥30kg/m2 * We will screen for participants with an echocardiogram within 60 days of the baseline visit	* Female participants who are pregnant, lactating, or of child bearing potential * History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c \>7.0% at Visit 1 * Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record * Any LVEF measure of ≤40% on past echocardiogram * Moderate or severe valve disease on echocardiogram * History of genitourinary infection * eGFR \<60 ml/min/1.73 m2 at Visit 1 * Current treatment with SGLT2 inhibitor, GLP1 agonist, or DPP4 inhibitors * Participants in whom coronary revascularization by either PCI or bypass surgery is being contemplated within 6 months, or who have undergone revascularization in the prior 2 months * Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations * Participants currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease * Any malignancy not considered cured (except basal cell carcinoma of the skin). A participant is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening * Participants who have participated in studies of an investigational drug or device within 30 days prior to the screening visit * Inadequate quality echocardiographic images * Unstable coronary syndromes * Major surgery (major according to the investigator's assessment) performed within 90 days prior to Visit 1 or scheduled major elective surgery within 90 days after Visit 1. * Non-English speaking individuals

Inclusion Criteria

Exclusion Criteria

* Age \>60 years of age
* Clinical diagnosis of hypertension
* Body mass index ≥30kg/m2
* We will screen for participants with an echocardiogram within 60 days of the baseline visit

* Female participants who are pregnant, lactating, or of child bearing potential
* History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c \>7.0% at Visit 1
* Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record
* Any LVEF measure of ≤40% on past echocardiogram
* Moderate or severe valve disease on echocardiogram
* History of genitourinary infection
* eGFR \<60 ml/min/1.73 m2 at Visit 1
* Current treatment with SGLT2 inhibitor, GLP1 agonist, or DPP4 inhibitors
* Participants in whom coronary revascularization by either PCI or bypass surgery is being contemplated within 6 months, or who have undergone revascularization in the prior 2 months
* Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations
* Participants currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease
* Any malignancy not considered cured (except basal cell carcinoma of the skin). A participant is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
* Participants who have participated in studies of an investigational drug or device within 30 days prior to the screening visit
* Inadequate quality echocardiographic images
* Unstable coronary syndromes
* Major surgery (major according to the investigator's assessment) performed within 90 days prior to Visit 1 or scheduled major elective surgery within 90 days after Visit 1.
* Non-English speaking individuals

Contacts and Locations

Study Contact

Julie Dicken, RN

CONTACT

dicke022@umn.edu

Principal Investigator

Jeremy Van't Hof, MD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Jeremy Van't Hof, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

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 Date2024-09-15

Study Completion Date2029-01-15

Study Record Updates

Study Start Date2024-09-15

Study Completion Date2029-01-15

Terms related to this study

Additional Relevant MeSH Terms

Hypertension
Cardiovascular Diseases