Clinical trial NCT05084235: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Obesity
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
name: Herlev and Gentofte Hospital
name: University Hospital Bispebjerg and Frederiksberg
name: Hillerod Hospital, Denmark
name: Rigshospitalet, Denmark
First posted: 2021-10-19
Enrollment: 191
Sex: ALL
Minimum age (years): 60
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Left ventricular mass index
timeFrame: 180 days
measure: Maximal oxygen consumption
timeFrame: 180 days
Secondary outcomes:
measure: Left ventricular volume
timeFrame: 180 days
measure: Left ventricular function
timeFrame: 180 days
measure: Daily activity level
timeFrame: 180 days
Other outcomes:
measure: Quality-of-life scores
timeFrame: 180 days
measure: Blood pressure
timeFrame: 180 days
measure: Wall stress
timeFrame: 180 days
measure: Left atrium size
timeFrame: 180 days
measure: Global strain
timeFrame: 180 days
measure: Growth differentiation factor 15
timeFrame: 180 days
measure: Cardiac fibrosis
timeFrame: 180 days
measure: Left atrium function
timeFrame: 180
measure: Biomarkers of heart disease
timeFrame: 180 days
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jacob Eifer Møller, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev-Gentofte Hospital
name: Morten Schou, MD, PhD, DmSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.