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

NCT05042973 | Completed Phase 2 DMC

• 1 other identifier: S-20210028-2
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Heart Failure

Keywords

Renal function; Glucose intolerance; Lipid metabolism

Outcome Measures

Primary Outcomes (2)

• Ventricular epicardial adipose tissue (EAT) mass

  Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)

  180 days

• Estimated extracellular volume (eECV)

  Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)

  180 days

Secondary Outcomes (4)

• Total pericardial adipose tissue volume

  180 days

• Total epicardial adipose tissue (EAT) volume

  180 days

• Plasma volume

  180 days

• Right ventricular end-diastolic volume index, RVEDVI

  180 days

Other Outcomes (10)

• Erythropoietin

  180 days

• Exploratory outcome: fat tissue gene expression

  180 days

• Exploratory outcome: oxidative stress and inflammation.

  180 days

Study Arms (2)

Active drug (Empagliflozin)

ACTIVE COMPARATOR

Empagliflozin 10 mg, 1 capsule per day

Drug: Empagliflozin 10 MG

Inactive drug (placebo)

PLACEBO COMPARATOR

Placebo, 1 capsule per day

Drug: Placebo

Interventions

Empagliflozin 10 MG DRUG

Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days

Active drug (Empagliflozin)

Placebo DRUG

Placebo matches the active drug in appearance, odor and labelling.

Inactive drug (placebo)

Eligibility Criteria

• Age: 60 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Andersen CF, Larsen JH, Jensen J, Omar M, Nouhravesh N, Kistorp C, Tuxen C, Gustafsson F, Knop FK, Forman JL, Davidovski FS, Jensen LT, Hojlund K, Kober L, Antonsen L, Poulsen MK, Schou M, Moller JE. Empagliflozin to elderly and obese patients with increased risk of developing heart failure: Study protocol for the Empire Prevent trial program. Am Heart J. 2024 May;271:84-96. doi: 10.1016/j.ahj.2024.02.005. Epub 2024 Feb 15.

  PMID: 38365073 DERIVED

MeSH Terms

Conditions

Obesity; Heart Failure; Glucose Intolerance

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Morten Schou, MD, PhD

  Herlev-Gentofte Hospital

  PRINCIPAL INVESTIGATOR

• Jacob Eifer Møller, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: September 2, 2021
• Primary Completion: January 16, 2025
• Study Completion: January 23, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)