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

Sponsor
Jacob Moller (Other)
Overall Status
Recruiting
CT.gov ID
NCT05042973
Collaborator
Danish Heart Foundation (Other), Herlev and Gentofte Hospital (Other), University Hospital Bispebjerg and Frederiksberg (Other), Hillerod Hospital, Denmark (Other), Rigshospitalet, Denmark (Other)
120
Enrollment
2
Locations
2
Arms
30.9
Anticipated Duration (Months)
60
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Empagliflozin 10 MG
  • Drug: Placebo
 Phase 2

Detailed Description

The EMPIRE II Metabolic is a part of the EMPIRE II Trial Program, which also comprises the EMPIRE II Cardiac.

The EMPIRE II Metabolic is designed to enroll at least 120 patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (EMPIRE II Metabolic): A Randomized Controlled Trial
Actual Study Start Date :
Sep 2, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Epicardial adipose tissue (EAT) [180 days]

    Between-group difference in the change of EAT volume assessed by cardiac MRI

  2. Estimated extracellular volume (eECV) [180 days]

    Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance

Secondary Outcome Measures

  1. Body composition [180 days]

    Between-group difference in the change in body composition assessed by DXA scan

  2. Plasma volume [180 days]

    Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin

  3. Glucose tolerance [180 days]

    Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test

  4. Kidney function (measured) [180 days]

    Between-group difference in the change of glomerular filtration rate assessed by 99mTc-DTPA clearance

  5. Kidney function (estimated) [180 days]

    Between-group difference in the change of estimated glomerular filtration based on the CKD-EPI estimation

  6. Uric acid [180 days]

    Between-group difference in the change of uric acid

  7. Urine albumin/creatinine ratio [180 days]

    Between-group difference in the change of urine albumin/creatinine ratio

  8. Right ventricle [180 days]

    Between-group difference in the change of right ventricular systolic and diastolic dimensions assessed by cardiac MRI

  9. Pericardial fat mass [180 days]

    Between-group difference in the change of pericardial fat mass assessed by cardiac MRI

  10. Ketone bodies [180 days]

    Between-group difference in the change of ketone supply to the heart assessed by blood ketones

  11. Erythropoietin [180 days]

    Between-group difference in the change of eryhtropoietin

Other Outcome Measures

  1. Exploratory outcome: fat tissue gene expression [180 days]

    Between-group difference in fat tissue gene expression assessed by Western Blot

  2. Exploratory outcome: oxidative stress and inflammation. [180 days]

    Between-group difference in biomarkers of oxidative stress and inflammation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Herlev Hospital Herlev Denmark 2730
2 Odense University Hospital Odense Denmark 5000

Sponsors and Collaborators

  • Jacob Moller
  • Danish Heart Foundation
  • Herlev and Gentofte Hospital
  • University Hospital Bispebjerg and Frederiksberg
  • Hillerod Hospital, Denmark
  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Morten Schou, MD, PhD, Herlev-Gentofte Hospital
  • Principal Investigator: Jacob Eifer Møller, MD, PhD, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacob Moller, Professor, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT05042973
Other Study ID Numbers:
  • S-20210028-2
First Posted:
Sep 13, 2021
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jacob Moller, Professor, MD, PhD, Odense University Hospital
Renal function
Glucose intolerance
Lipid metabolism
Additional relevant MeSH terms:
Heart Failure
Empagliflozin

Study Results

No Results Posted as of Sep 13, 2021