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Completed

NCT Number: NCT05084235

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

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.

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Key information

Conditions

Heart Failure Body Weight Cardiovascular Diseases Heart Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herlev Hospital, Herlev, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin 10 MG

Drug

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

Placebo

Drug

Placebo matches the active drug in appearance, odor and labelling

Primary outcomes

  1. Left ventricular mass index

    Time frame: 180 days

    Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image

  2. Maximal oxygen consumption

    Time frame: 180 days

    Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test

Secondary outcomes

  1. Left ventricular volume

    Time frame: 180 days

    Between-group difference in the change of left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI) assessed by cardiac magnetic resonance image

  2. Left ventricular function

    Time frame: 180 days

    Between-group difference in the change of first phase ejection fraction and left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance image

  3. Daily activity level

    Time frame: 180 days

    Between-group difference in the change of daily activity level assessed by accelerometer

Other outcomes

  1. Quality-of-life scores

    Time frame: 180 days

    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.

  2. Blood pressure

    Time frame: 180 days

    Between-group difference in the change of systolic and diastolic blood pressure assessed by ambulatory blood pressure measurement

  3. Wall stress

    Time frame: 180 days

    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)

  4. Left atrium size

    Time frame: 180 days

    Between-group difference in the change of left atrial maximal and minimal size measured by cardiac magnetic resonance image

  5. Global strain

    Time frame: 180 days

    Between-group difference in the change of global strain assessed by cardiac magnetic resonance image

  6. Growth differentiation factor 15

    Time frame: 180 days

    Between-group difference in the change of the biomarker growth differentiation factor 15 (pg/ml)

  7. Cardiac fibrosis

    Time frame: 180 days

    Between-group difference in the change of cardiac fibrosis assessed by cardiac magnetic resonance image

  8. Left atrium function

    Time frame: 180

    Between-group difference in the change of left atrial emptying fraction and left atrium ejection fraction assessed by cardiac magnetic resonance image

  9. Biomarkers of heart disease

    Time frame: 180 days

    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.

Sponsors and collaborators

Lead sponsor

Jacob Moller

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2021
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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