Empagliflozin to elderly and obese patients with cardiovascular disease (EMPIRE II): A randomized controlled trial

Phase 1

• Conditions: Obese patients (BMI >28 kg/m2), aged 60-84 years, with documented risk factors for developing heart failurebut no history of diabetes mellitus or heart failure with reduced ejection fraction.; MedDRA version: 20.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005317-40-DK
• Lead Sponsor: Odense University Hospital - Department of Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-07
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

(1)Age 60-84 years
(2) Bodymass index >28 kg/m2
(3) Documented risk factors for developing heart failure, i.e. one-of following :
(3a) Hypertension
(3b) Documented ischemic heart disease
(3c) Stroke or transitory cerebral ischemia
(3d) Chronic kidney disease with GFR 30-45 ml/min/1,72m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104

Exclusion Criteria

(1) Diabetes mellitus (type 1 or 2)
(2) Heart failure with ejection fraction <40%
(3) Inability to perform exercise test
(4) Dementia
(5) Non-compliance
(6) Substance abuse
(7) GFR <30 ml/min/1,72m2
(8) Severe chronic obstructive pulmonary disease (FEV1< 50% expected value)
(9) Permanent atrial fibrillation
(10) Severe peripheral artery disease
(11) Cancer treatment within one year beside prostate cancer and basal cell carcinoma
(12) Severe aortic or mitral valve disease
(13) Acute hospital admission within 30 days
(14) Participation in other pharmacological study
(15) Pregnancy
(16) Breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified