This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.
NCT ID: NCT03448406
Last Updated: 2020-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
315 participants
INTERVENTIONAL
2018-03-20
2019-10-09
Brief Summary
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Secondary objectives are to assess Patient-Reported Outcome (PRO)
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Empagliflozin
Empagliflozin
Film-coated tablet
Placebo
Placebo
Film-coated tablet
Interventions
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Empagliflozin
Film-coated tablet
Placebo
Film-coated tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female patients. Women of child bearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
* Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial
* Six minute walk test (6MWT) distance ≤350 m at screening and at baseline.
* Patients with CHF diagnosed for at least 3 months before Visit 1, and currently in NYHA class II-IV
* Chronic heart failure (CHF) with preserved Ejection fraction (EF) defined as left ventricle ejection fraction(LVEF) \> 40 % as per echocardiography at Visit 1 per local reading and no prior measurement of LVEF ≤ 40% under stable conditions.
* Elevated N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) \> 300 pg/ml for patients without atrial fibrillation (AF), OR \> 600 pg/ml for patients with AF, as analysed at the Central laboratory at Visit 1
* Patients must have at least one of the following evidence of heart failure (HF):
* Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1, OR
* Documented Hospitalization for Heart Failure (HHF) within 12 months prior to Visit 1
* Consistent with prevailing CV guidelines, if oral diuretics are prescribed to control symptoms, patients must be on an appropriate and stable dose of oral diuretics for at least 2 weeks prior to Visit 1 to control symptoms.
* Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).
Exclusion Criteria
* Acute decompensated HF (exacerbation of CHF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
* Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0168)
* Type 1 Diabetes Mellitus (T1DM)
* Impaired renal function, defined as eGFR \< 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
* Symptomatic hypotension or a systolic blood pressure (SBP) \< 100 mmHg at Visit 1 or 2
* SBP ≥ 180 mmHg at Visit 1 or 2, or SBP \>160mmHg at both Visit 1 and 2
* Atrial fibrillation or atrial flutter with a resting heart rate \> 110 bpm documented by ECG at Visit 1 (Screening)
* Unstable angina pectoris in past 30 days prior to Visit 1
* Largest distance walked in 6 minutes (6MWTD) at baseline \<100m.
* Any presence of condition that precludes exercise testing such as:
* claudication,
* uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
* significant musculoskeletal disease,
* primary pulmonary hypertension,
* severe obesity (body mass index ≥40.0 kg/m2),
* orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
* amputation with artificial limb without stable prosthesis function for the past 3 months
* Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWT
* Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
* ICD implantation within 1 month prior to Visit 1 or planned during the course of the trial
* Implanted cardiac resynchronisation therapy (CRT)
* Treatment with i.v. iron therapy or erythropoietin (EPO) within 3 months prior to screening.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Mobile Heart Specialists, PC
Mobile, Alabama, United States
The Center for Clinical Trials, Inc.
Saraland, Alabama, United States
California Heart Specialists
Huntington Beach, California, United States
Manshadi Heart Institute, Inc
Stockton, California, United States
University of California Los Angeles
Torrance, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Western Connecticut Health Network
Danbury, Connecticut, United States
Infinite Clinical Research
Miami, Florida, United States
Advance Medical Research Center
Miami, Florida, United States
Bio1 Clinical Research
Miami Beach, Florida, United States
Pharmacology Research, LLC
North Miami Beach, Florida, United States
Palm Beach Gardens Research Center, LLC
Palm Beach Gardens, Florida, United States
East Coast Institute for Research, LLC
Saint Augustine, Florida, United States
Cozy Research LLC
Zephyrhills, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Georgia Arrhythmia Consultants and Research Institute
Warner Robins, Georgia, United States
St Luke's Clinic - Idaho Cardiology Associates
Boise, Idaho, United States
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, United States
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States
Chicago Medical Research
Hazel Crest, Illinois, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States
Grace Research, LLC
Bossier City, Louisiana, United States
Grace Research, LLC
Shreveport, Louisiana, United States
Clinical Trials of America LA, LLC
West Monroe, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
John D. Dingell VA Medical Center
Detroit, Michigan, United States
Med Research One
Florissant, Missouri, United States
Cox Medical Center South
Springfield, Missouri, United States
The DOCS
Las Vegas, Nevada, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Albany Stratton VA Medical Center Albany, NY
Albany, New York, United States
UNC REX Healthcare
Raleigh, North Carolina, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Rama Research LLC
Marion, Ohio, United States
Columbia Heart Clinic
Columbia, South Carolina, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
DiscoveResearch, Inc.
Beaumont, Texas, United States
Angiocardiac Care of Texas
Houston, Texas, United States
Acacia Medical Research Institute,LLC
Sugar Land, Texas, United States
Mary Washington Hospital Research Department
Fredericksburg, Virginia, United States
York Clinical Research, LLC
Norfolk, Virginia, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
University of the Sunshine Coast
Birtinya, Queensland, Australia
Peninsular Health CV Research Unit
Frankston, Victoria, Australia
University of Calgary
Calgary, Alberta, Canada
KMH Cardiology Centres Inc.
Mississauga, Ontario, Canada
Toronto Heart Centre
Toronto, Ontario, Canada
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario, Canada
CIMS Studienzentrum Bamberg GmbH
Bamberg, , Germany
Klinische Forschung Berlin GbR
Berlin, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Cardiologicum Dresden und Pirna
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
IKF Pneumologie GmbH & Co. KG
Frankfurt, , Germany
Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
Freiburg im Breisgau, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitätsklinikum Magdeburg AöR
Magdeburg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
General Hospital of Athens Konstantopoulio-Agia Olga
Athens, , Greece
General Hospital of Athens "G. Gennimatas"
Athens, , Greece
General Hospital of Chalkida
Chalcis, , Greece
University General Hospital of Heraklion
Herakleion, Crete, , Greece
Univ. Gen. Hosp. of Ioannina
Ioannina, , Greece
University Hospital of Thessaloniki AHEPA
Thessaloniki, , Greece
Centro Cardiologico Monzino-IRCCS
Milan, , Italy
Asst Santi Paolo E Carlo
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Ospedale Regina Montis Regalis
Mondovì (CN), , Italy
Università Federico II
Napoli, , Italy
Università degli studi di Palermo
Palermo, , Italy
IRCCS San Raffaele
Roma, , Italy
Sykehuset Østfold Kalnes
Grålum, , Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, , Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, , Norway
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, , Norway
INTERCORE Medical Center
Bydgoszcz, , Poland
10.Military Clin.Hospital&Polyclinic
Bydgoszcz, , Poland
Leszek Bryniarski Specialized Medical Cabinet
Krakow, , Poland
Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz
Lodz, , Poland
Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard
Lodz, , Poland
Provincial Specialist M. Kopernik Hospital
Lodz, , Poland
Independent Public Healthcare, Dept. of Cardiology, Pulawy
Puławy, , Poland
Central Hospital of Medical Academy, Warsaw
Warsaw, , Poland
4. Military Clinical Hospital with Polyclinic SP ZOZ
Wroclaw, , Poland
CHLO, EPE - Hospital de Santa Cruz
Carnaxide, , Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, , Portugal
Centro Hosp. de Leiria-Pombal
Leiria, , Portugal
CHLC, EPE - Hospital de Santa Marta
Lisbon, , Portugal
CHLO, EPE - Hospital S. Francisco Xavier
Lisbon, , Portugal
CHULN, EPE - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar Universitário São João,EPE
Porto, , Portugal
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital San Rafael
Granada, , Spain
Hospital de la Inmaculada Concepción
Granada, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
Sahlgrenska US, Göteborg
Gothenburg, , Sweden
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, , Sweden
Skånes universitetssjukhus, Lund
Lund, , Sweden
Akardo Med Site
Stockholm, , Sweden
Countries
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References
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Anker SD, Ponikowski P, Wanner C, Pfarr E, Hauske S, Peil B, Salsali A, Ritter I, Koitka-Weber A, Brueckmann M, Lindenfeld J, Abraham WT; EMPERIAL Investigators and National Coordinators. Kidney Function After Initiation and Discontinuation of Empagliflozin in Patients With Heart Failure With and Without Type 2 Diabetes: Insights From the EMPERIAL Trials. Circulation. 2021 Oct 12;144(15):1265-1267. doi: 10.1161/CIRCULATIONAHA.121.054669. Epub 2021 Aug 16. No abstract available.
Abraham WT, Ponikowski P, Brueckmann M, Zeller C, Macesic H, Peil B, Brun M, Ustyugova A, Jamal W, Salsali A, Lindenfeld J, Anker SD; EMPERIAL Investigators and National Coordinators. Rationale and design of the EMPERIAL-Preserved and EMPERIAL-Reduced trials of empagliflozin in patients with chronic heart failure. Eur J Heart Fail. 2019 Jul;21(7):932-942. doi: 10.1002/ejhf.1486. Epub 2019 Jun 19.
Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2017-004072-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1245-0167
Identifier Type: -
Identifier Source: org_study_id