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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084235
• Other study ID #: S-20210028-1
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2023
• Source: Odense University Hospital
• Contact: Julie Hemepel Larsen, MD
• Phone: +45 28935466
• Email: julie.hempel.larsen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: April 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Obesity

Intervention

Drug:
• Empagliflozin 10 MG
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
• Placebo
Placebo matches the active drug in appearance, odor and labelling

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (6)

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

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular mass index	Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image	180 days
Primary	Maximal oxygen consumption	Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test	180 days
Secondary	Daily activity level	Between-group difference in the change of daily activity level assessed by accelerometer	180 days
Secondary	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.	180 days
Secondary	Cardiac fibrosis	Between-group difference in the change of cardiac fibrosis assessed by cardiac magnetic resonance image	180 days
Secondary	Blood pressure	Between-group difference in the change of systolic and diastolic blood pressure assessed by ambulatory blood pressure measurement	180 days
Secondary	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)	180 days
Secondary	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	180 days
Secondary	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	180 days
Secondary	Left atrium size	Between-group difference in the change of left atrial maximal and minimal size measured by cardiac magnetic resonance image	180 days
Secondary	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	180
Secondary	Global strain	Between-group difference in the change of global strain assessed by cardiac magnetic resonance image	180 days
Secondary	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.	180 days
Secondary	Growth differentiation factor 15	Between-group difference in the change of the biomarker growth differentiation factor 15 (pg/ml)	180 days