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

Primary Purpose

Heart Failure, Obesity

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Empagliflozin 10 MG
Placebo
Sponsored by
Jacob Moller
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

60 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev HospitalRecruiting
  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Empaglifloxin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Left ventricular mass index
Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image
Maximal oxygen consumption
Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test

Secondary Outcome Measures

Daily activity level
Between-group difference in the change of daily activity level assessed by accelerometer
Quality-of-life scores
Between-group difference in the change of self-reported quality of life assessed by the 36-item short form health survey (SF-36 questionnaire). The SF-36 targets eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a scale from 0 to 100, with a higher score representing a more favorable health state. An average score is calculated for each health concept.
Cardiac fibrosis
Between-group difference in the change of cardiac fibrosis assessed by cardiac magnetic resonance image
Blood pressure
Between-group difference in the change of systolic and diastolic blood pressure assessed by ambulatory blood pressure measurement
Wall stress
Between-group difference in the change of estimated end-systolic wall stress (ESWS). ESWS will be calculated from results of multimodality imaging combining MRI and echocardiography by using a formula incorporating MRI LV end-systolic diameter and wall thickness as well as echocardiographic mean and arterial blood pressure as proposed by Reichek et al. based on the Law of Laplace. (please see references Reichek et al and Carter-Storch et al. in the reference list)
Left ventricular function
Between-group difference in the change of first phase ejection fraction and left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance image
Left ventricular volume
Between-group difference in the change of left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) assessed by cardiac magnetic resonance image
Left atrium size
Between-group difference in the change of left atrial maximal and minimal size measured by cardiac magnetic resonance image
Left atrium function
Between-group difference in the change of left atrial emptying fraction and left atrium ejection fraction assessed by cardiac magnetic resonance image
Global strain
Between-group difference in the change of global strain assessed by cardiac magnetic resonance image
Biomarkers of heart disease
Between-group difference in the change of biomarkers of heart disease, including atrial natriuretic peptide (ANP), brain (B-type) natriuretic peptide (BNP), and N-terminal pro-hormone BNP (NT-proBNP). All measured as pmol/L.
Growth differentiation factor 15
Between-group difference in the change of the biomarker growth differentiation factor 15 (pg/ml)

Full Information

First Posted
September 3, 2021
Last Updated
April 5, 2023
Sponsor
Jacob Moller
Collaborators
Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05084235
Brief Title
The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure
Official Title
Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Cardiac): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacob Moller
Collaborators
Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. The primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1) reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption) compared with placebo.
Detailed Description
The Empire Prevent: Cardiac is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Metabolic

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empaglifloxin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matches the active drug in appearance, odor and labelling
Primary Outcome Measure Information:
Title
Left ventricular mass index
Description
Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image
Time Frame
180 days
Title
Maximal oxygen consumption
Description
Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Daily activity level
Description
Between-group difference in the change of daily activity level assessed by accelerometer
Time Frame
180 days
Title
Quality-of-life scores
Description
Between-group difference in the change of self-reported quality of life assessed by the 36-item short form health survey (SF-36 questionnaire). The SF-36 targets eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a scale from 0 to 100, with a higher score representing a more favorable health state. An average score is calculated for each health concept.
Time Frame
180 days
Title
Cardiac fibrosis
Description
Between-group difference in the change of cardiac fibrosis assessed by cardiac magnetic resonance image
Time Frame
180 days
Title
Blood pressure
Description
Between-group difference in the change of systolic and diastolic blood pressure assessed by ambulatory blood pressure measurement
Time Frame
180 days
Title
Wall stress
Description
Between-group difference in the change of estimated end-systolic wall stress (ESWS). ESWS will be calculated from results of multimodality imaging combining MRI and echocardiography by using a formula incorporating MRI LV end-systolic diameter and wall thickness as well as echocardiographic mean and arterial blood pressure as proposed by Reichek et al. based on the Law of Laplace. (please see references Reichek et al and Carter-Storch et al. in the reference list)
Time Frame
180 days
Title
Left ventricular function
Description
Between-group difference in the change of first phase ejection fraction and left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance image
Time Frame
180 days
Title
Left ventricular volume
Description
Between-group difference in the change of left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) assessed by cardiac magnetic resonance image
Time Frame
180 days
Title
Left atrium size
Description
Between-group difference in the change of left atrial maximal and minimal size measured by cardiac magnetic resonance image
Time Frame
180 days
Title
Left atrium function
Description
Between-group difference in the change of left atrial emptying fraction and left atrium ejection fraction assessed by cardiac magnetic resonance image
Time Frame
180
Title
Global strain
Description
Between-group difference in the change of global strain assessed by cardiac magnetic resonance image
Time Frame
180 days
Title
Biomarkers of heart disease
Description
Between-group difference in the change of biomarkers of heart disease, including atrial natriuretic peptide (ANP), brain (B-type) natriuretic peptide (BNP), and N-terminal pro-hormone BNP (NT-proBNP). All measured as pmol/L.
Time Frame
180 days
Title
Growth differentiation factor 15
Description
Between-group difference in the change of the biomarker growth differentiation factor 15 (pg/ml)
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Hemepel Larsen, MD
Phone
+45 28935466
Email
julie.hempel.larsen@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Fuchs Andersen
Phone
+45 28144737
Email
camilla.fuchs.andersen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Eifer Møller, MD, PhD,
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Morten Schou, MD, PhD, DmSc
Organizational Affiliation
Herlev-Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla F Andersen, MD
Phone
+45 28144737
Email
camilla.fuchs.andersen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Professor Morten Schou, MD, PhD
First Name & Middle Initial & Last Name & Degree
Camilla F Andersen, MD
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie H Larsen, MD
Phone
+45 28935466
Email
Julie.Hempel.Larsen@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Professor Jacob E Møller, MD, PhD
First Name & Middle Initial & Last Name & Degree
Julie H Larsen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7053293
Citation
Reichek N, Wilson J, St John Sutton M, Plappert TA, Goldberg S, Hirshfeld JW. Noninvasive determination of left ventricular end-systolic stress: validation of the method and initial application. Circulation. 1982 Jan;65(1):99-108. doi: 10.1161/01.cir.65.1.99. No abstract available.
Results Reference
background
PubMed Identifier
31168387
Citation
Carter-Storch R, Moller JE, Christensen NL, Rasmussen LM, Pecini R, Sondergard E, Videbaek LM, Dahl JS. End-systolic wall stress in aortic stenosis: comparing symptomatic and asymptomatic patients. Open Heart. 2019 Apr 9;6(1):e001021. doi: 10.1136/openhrt-2019-001021. eCollection 2019.
Results Reference
background

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

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