The Metabolic Effects of Empagliflozin in Patients With High Risk of Heart Failure

January 26, 2025 updated by: Jacob Moller

Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Metabolic): A Randomized Controlled Trial

The aim of this trial is to assess the effect of Empagliflozin on lipid and glucose metabolism as well as volume homeostasis and renal function in elderly and obese patients with increased risk of developing heart failure. No history of established heart failure or diabetes is allowed.

The primary hypotheses are that 6 months treatment with Empagliflozin 10 mg a day will: 1) decrease epicardial adipose tissue volume, and 2) reduce estimated extracellular volume compared with placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Empire Prevent: Metabolic is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Cardiac.

The Empire Prevent: Metabolic is designed to enroll at least 120 patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body mass index >28kg/m2
  • Age 60-84 years
  • Established risk factor for developing heart failure, defined as at least one of the following:
  • hypertension
  • ischemic heart disease
  • stroke/transient cerebral ischemia
  • chronic kidney disease (eGFR 30-45ml/min/1.73m2)

Exclusion Criteria:

  • Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)
  • Heart failure with reduced ejection fraction (LVEF <40%)
  • Inability to perform exercise test
  • Dementia
  • Severe non-compliance
  • Substance abuse
  • Severe chronic obstructive pulmonary disease (FEV1<50% expected value)
  • Permanent atrial fibrillation
  • GFR <30 ml/min/1,73m2
  • Severe peripheral artery disease
  • Cancer treatment within one year beside prostate cancer and basal cell carcinoma
  • Severe aortic or mitral valve disease
  • Pregnancy or breastfeeding
  • Acute hospital admission within 30 days
  • Participation in other pharmacological study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active drug (Empagliflozin)
Empagliflozin 10 mg, 1 capsule per day
Drug: Empagliflozin 10 MG
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
Placebo Comparator: Inactive drug (placebo)
Placebo, 1 capsule per day
Drug: Placebo
Placebo matches the active drug in appearance, odor and labelling.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Estimated extracellular volume (eECV)
Time Frame: 180 days
Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)
180 days
Ventricular epicardial adipose tissue (EAT) mass
Time Frame: 180 days
Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma volume
Time Frame: 180 days
Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
180 days
Total pericardial adipose tissue volume
Time Frame: 180 days
Between-group difference in the change of pericardial adipose tissue volume assessed by cardiac MRI
180 days
Total epicardial adipose tissue (EAT) volume
Time Frame: 180 days
Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
180 days
Right ventricular end-diastolic volume index, RVEDVI
Time Frame: 180 days
Between-group difference in the change of RVEDVI assessed by cardiac MRI
180 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 180 days
Between-group difference in the change in body composition assessed by dual energy x-ray absorptiometry (DXA) scan
180 days
Glucose tolerance
Time Frame: 180 days
Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test
180 days
Kidney function (measured)
Time Frame: 180 days
Between-group difference in the change of glomerular filtration rate assessed by 99mTc-DTPA clearance
180 days
Kidney function (estimated)
Time Frame: 180 days
Between-group difference in the change of estimated glomerular filtration rate (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) estimation
180 days
Uric acid
Time Frame: 180 days
Between-group difference in the change of uric acid
180 days
Urine albumin/creatinine ratio
Time Frame: 180 days
Between-group difference in the change of urine albumin/creatinine ratio
180 days
Ketone bodies
Time Frame: 180 days
Between-group difference in the change of ketone supply to the heart assessed by blood ketones
180 days
Erythropoietin
Time Frame: 180 days
Between-group difference in the change of erythropoietin
180 days
Exploratory outcome: fat tissue gene expression
Time Frame: 180 days
Between-group difference in fat tissue gene expression assessed by Western Blot
180 days
Exploratory outcome: oxidative stress and inflammation.
Time Frame: 180 days
Between-group difference in biomarkers of oxidative stress and inflammation.
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jacob Moller

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rigshospitalet, Denmark
University Hospital Bispebjerg and Frederiksberg
Hillerod Hospital, Denmark
Herlev and Gentofte Hospital
Danish Heart Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Morten Schou, MD, PhD, Herlev-Gentofte Hospital
  • Principal Investigator: Jacob Eifer Møller, MD, PhD, Odense University Hospital

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-20210028-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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