Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
NCT ID: NCT03521934
Last Updated: 2022-10-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1222 participants
INTERVENTIONAL
2018-06-15
2020-06-05
Brief Summary
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To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF)
Secondary Objectives:
To compare the effects of sotagliflozin to placebo on:
* The total occurrences of HHF and urgent visit for HF
* The occurrence of CV death
* The occurrence of all-cause mortality
* The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke
* Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score
* Change in estimated glomerular filtration rate (eGFR)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sotagliflozin
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
Sotagliflozin
Pharmaceutical form: tablet
Route of administration: oral
Placebo
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
Placebo
Pharmaceutical form: tablet
Route of administration: oral
Interventions
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Sotagliflozin
Pharmaceutical form: tablet
Route of administration: oral
Placebo
Pharmaceutical form: tablet
Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to the hospital, or urgent heart failure visit for worsening heart failure.
* Prior diagnosis of heart failure (\> 3 months).
* Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for \> 30 days.
* Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge.
* Brain natriuretic peptide (BNP) ≥150 picograms per milliliter (pg/mL) (≥450 pg/mL for participants with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for participants with atrial fibrillation).
* Participants with Left Ventricular Ejection Fraction \<40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated.
* Signed written informed consent.
Exclusion Criteria
* Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack.
* Cardiac surgery or coronary procedure within 1 month or planned during study.
* Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.
* Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.
* Acute coronary syndromes within 3 months prior to Randomization.
* Hemodynamically significant uncorrected primary valvular disease.
* Significant pulmonary disease contributing substantially to the participant's dyspnea.
* End stage Heart Failure.
* History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening.
* History of stroke within 3 months prior to randomization.
* History of dialysis within 1 year prior to randomization.
* History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant).
* Severe kidney disease as defined by glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.72 meter square (mL/min/1.73 m\^2).
* Pregnancy.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
85 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Suman Wason, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Investigational Site Number 8400128
Alexander City, Alabama, United States
Investigational Site Number 8400109
Cottonwood, Arizona, United States
Investigational Site Number 8400032
Little Rock, Arkansas, United States
Investigational Site Number 8400080
Little Rock, Arkansas, United States
Investigational Site Number 8400075
Bakersfield, California, United States
Investigational Site Number 8400069
Fresno, California, United States
Investigational Site Number 8400008
Los Angeles, California, United States
Investigational Site Number 8400063
Los Angeles, California, United States
Investigational Site Number 8400127
National City, California, United States
Investigational Site Number 8400007
Redondo Beach, California, United States
Investigational Site Number 8400036
Stockton, California, United States
Investigational Site Number 8400033
Sylmar, California, United States
Investigational Site Number 8400049
Torrance, California, United States
Investigational Site Number 8400028
Walnut Creek, California, United States
Investigational Site Number 8400029
Bridgeport, Connecticut, United States
Investigational Site Number 8400037
New Haven, Connecticut, United States
Investigational Site Number 8400046
DeLand, Florida, United States
Investigational Site Number 8400009
Gainesville, Florida, United States
Investigational Site Number 8400079
Homestead, Florida, United States
Investigational Site Number 8400031
Jacksonville, Florida, United States
Investigational Site Number 8400022
Jacksonville, Florida, United States
Investigational Site Number 8400098
Lake Mary, Florida, United States
Investigational Site Number 8400058
Miami Beach, Florida, United States
Investigational Site Number 8400105
Orlando, Florida, United States
Investigational Site Number 8400082
Pensacola, Florida, United States
Investigational Site Number 8400057
Port Charlotte, Florida, United States
Investigational Site Number 8400006
Sarasota, Florida, United States
Investigational Site Number 8400035
Tampa, Florida, United States
Investigational Site Number 8400042
Tampa, Florida, United States
Investigational Site Number 8400004
Wellington, Florida, United States
Investigational Site Number 8400073
Atlanta, Georgia, United States
Investigational Site Number 8400118
Tucker, Georgia, United States
Investigational Site Number 8400067
Arlington Heights, Illinois, United States
Investigational Site Number 8400043
Chicago, Illinois, United States
Investigational Site Number 8400072
Elk Grove Village, Illinois, United States
Investigational Site Number 8400055
Indianapolis, Indiana, United States
Investigational Site Number 8400020
Muncie, Indiana, United States
Investigational Site Number 8400122
Richmond, Indiana, United States
Investigational Site Number 8400091
Waterloo, Iowa, United States
Investigational Site Number 8400030
Covington, Louisiana, United States
Investigational Site Number 8400065
Annapolis, Maryland, United States
Investigational Site Number 8400012
Boston, Massachusetts, United States
Investigational Site Number 8400001
Cambridge, Massachusetts, United States
Investigational Site Number 8400077
Detroit, Michigan, United States
Investigational Site Number 8400062
Kalamazoo, Michigan, United States
Investigational Site Number 8400017
Kalamazoo, Michigan, United States
Investigational Site Number 8400107
Duluth, Minnesota, United States
Investigational Site Number 8400056
Jackson, Mississippi, United States
Investigational Site Number 8400019
Columbia, Missouri, United States
Investigational Site Number 8400103
Lee's Summit, Missouri, United States
Investigational Site Number 8400132
Grand Island, Nebraska, United States
Investigational Site Number 8400130
Lincoln, Nebraska, United States
Investigational Site Number 8400083
Omaha, Nebraska, United States
Investigational Site Number 8400071
Omaha, Nebraska, United States
Investigational Site Number 8400015
Ridgewood, New Jersey, United States
Investigational Site Number 8400050
Voorhees Township, New Jersey, United States
Investigational Site Number 8400131
Albuquerque, New Mexico, United States
Investigational Site Number 8400051
Brooklyn, New York, United States
Investigational Site Number 8400111
Buffalo, New York, United States
Investigational Site Number 8400097
The Bronx, New York, United States
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The Bronx, New York, United States
Investigational Site Number 8400045
Greensboro, North Carolina, United States
Investigational Site Number 8400085
Raleigh, North Carolina, United States
Investigational Site Number 8400078
Winston-Salem, North Carolina, United States
Investigational Site Number 8400087
Cincinnati, Ohio, United States
Investigational Site Number 8400047
Cincinnati, Ohio, United States
Investigational Site Number 8400095
Maumee, Ohio, United States
Investigational Site Number 8400099
Toledo, Ohio, United States
Investigational Site Number 8400121
Zanesville, Ohio, United States
Investigational Site Number 8400054
Arlington, Oregon, United States
Investigational Site Number 8400134
Doylestown, Pennsylvania, United States
Investigational Site Number 8400044
Natrona Heights, Pennsylvania, United States
Investigational Site Number 8400115
Philadelphia, Pennsylvania, United States
Investigational Site Number 8400039
Sayre, Pennsylvania, United States
Investigational Site Number 8400114
Providence, Rhode Island, United States
Investigational Site Number 8400100
Warwick, Rhode Island, United States
Investigational Site Number 8400059
Charleston, South Carolina, United States
Investigational Site Number 8400092
Columbia, South Carolina, United States
Investigational Site Number 8400104
Greenville, South Carolina, United States
Investigational Site Number 8400040
Rapid City, South Dakota, United States
Investigational Site Number 8400088
Greenville, Tennessee, United States
Investigational Site Number 8400089
Memphis, Tennessee, United States
Investigational Site Number 8400053
Nashville, Tennessee, United States
Investigational Site Number 8400041
Brownsville, Texas, United States
Investigational Site Number 8400074
Dallas, Texas, United States
Investigational Site Number 8400016
Houston, Texas, United States
Investigational Site Number 8400123
McKinney, Texas, United States
Investigational Site Number 8400101
New Braunfels, Texas, United States
Investigational Site Number 8400066
Victoria, Texas, United States
Investigational Site Number 8400093
Manassas, Virginia, United States
Investigational Site Number 8400003
Richmond, Virginia, United States
Investigational Site Number 8400126
Clarksburg, West Virginia, United States
Investigational Site Number 8400038
Morgantown, West Virginia, United States
Investigational Site Number 8400048
Manitowoc, Wisconsin, United States
Investigational Site Number 0320031
Caba, , Argentina
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Caba, , Argentina
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Capital Federal, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Corrientes, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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La Plata, , Argentina
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La Plata, , Argentina
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Merlo, , Argentina
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Morón, , Argentina
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Olivos, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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Salta, , Argentina
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San Martín, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Santa Fe, , Argentina
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Villa Belgrano, , Argentina
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Villa María, , Argentina
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Murdoch, , Australia
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Wollongong, , Australia
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Braunau am Inn, , Austria
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Feldkirch, , Austria
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Graz, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Aalst, , Belgium
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Ghent, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Mol, , Belgium
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Mons, , Belgium
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Roeselare, , Belgium
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Belo Horizonte, , Brazil
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Belo Horizonte, , Brazil
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Blumenau, , Brazil
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Brasília, , Brazil
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Campinas, , Brazil
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Campinas, , Brazil
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Fortaleza, , Brazil
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Goiânia, , Brazil
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Passo Fundo, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Votuporanga, , Brazil
Investigational Site Number 1240013
Cambridge, , Canada
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Granby, , Canada
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Halifax, , Canada
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Montreal, , Canada
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Montreal, , Canada
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Montreal, , Canada
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Peterborough, , Canada
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Québec, , Canada
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Scarborough, , Canada
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Sherbrooke, , Canada
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Toronto, , Canada
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Toronto, , Canada
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Trois-Rivières, , Canada
Investigational Site Number 1520009
Concepción, , Chile
Investigational Site Number 1520011
Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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Viña del Mar, , Chile
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Brno, , Czechia
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Brno, , Czechia
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Brno, , Czechia
Investigational Site Number 2030014
Kolín, , Czechia
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Kroměříž, , Czechia
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Liberec, , Czechia
Investigational Site Number 2030013
Městec Králové, , Czechia
Investigational Site Number 2030018
Prague, , Czechia
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Prague, , Czechia
Investigational Site Number 2030017
Prague, , Czechia
Investigational Site Number 2030007
Praha 5 - Motol, , Czechia
Investigational Site Number 2030015
Pribram I, , Czechia
Investigational Site Number 2030011
Přerov, , Czechia
Investigational Site Number 2030006
Slaný, , Czechia
Investigational Site Number 2080004
Aalborg, , Denmark
Investigational Site Number 2080003
Aarhus N, , Denmark
Investigational Site Number 2080002
Glostrup Municipality, , Denmark
Investigational Site Number 2080001
Herlev, , Denmark
Investigational Site Number 2080005
København NV, , Denmark
Investigational Site Number 2460004
Espoo, , Finland
Investigational Site Number 2460001
Helsinki, , Finland
Investigational Site Number 2460002
Jyväskylä, , Finland
Investigational Site Number 2460003
Oulu, , Finland
Investigational Site Number 2460005
Seinäjoki, , Finland
Investigational Site Number 2500009
Chambray-lès-Tours, , France
Investigational Site Number 2500008
La Tronche, , France
Investigational Site Number 2500004
Le Chesnay, , France
Investigational Site Number 2500002
Le Coudray, , France
Investigational Site Number 2500001
Lille, , France
Investigational Site Number 2500007
Nantes, , France
Investigational Site Number 2500012
Nice, , France
Investigational Site Number 2500006
Paris, , France
Investigational Site Number 2500003
Paris, , France
Investigational Site Number 2500005
Toulouse, , France
Investigational Site Number 2500013
Vandœuvre-lès-Nancy, , France
Investigational Site Number 2760020
Bad Nauheim, , Germany
Investigational Site Number 2760016
Bad Oeynhausen, , Germany
Investigational Site Number 2760013
Berlin, , Germany
Investigational Site Number 2760019
Berlin, , Germany
Investigational Site Number 2760001
Berlin, , Germany
Investigational Site Number 2760002
Berlin, , Germany
Investigational Site Number 2760025
Bielefeld, , Germany
Investigational Site Number 2760005
Bonn, , Germany
Investigational Site Number 2760021
Bremen, , Germany
Investigational Site Number 2760035
Coburg, , Germany
Investigational Site Number 2760027
Cologne, , Germany
Investigational Site Number 2760032
Dortmund, , Germany
Investigational Site Number 2760006
Dortmund, , Germany
Investigational Site Number 2760029
Erfurt, , Germany
Investigational Site Number 2760018
Essen, , Germany
Investigational Site Number 2760033
Frankfurt am Main, , Germany
Investigational Site Number 2760009
Greifswald, , Germany
Investigational Site Number 2760022
Heidelberg, , Germany
Investigational Site Number 2760031
Heidelberg, , Germany
Investigational Site Number 2760034
Lahr, , Germany
Investigational Site Number 2760030
Langen, , Germany
Investigational Site Number 2760014
Leverkusen, , Germany
Investigational Site Number 2760036
Limburg, , Germany
Investigational Site Number 2760012
Ludwigshafen, , Germany
Investigational Site Number 2760028
Merseburg, , Germany
Investigational Site Number 2760011
Rotenburg an der Fulda, , Germany
Investigational Site Number 2760015
Rüsselsheim am Main, , Germany
Investigational Site Number 2760007
Witten, , Germany
Investigational Site Number 2760026
Würzburg, , Germany
Investigational Site Number 3000012
Athens, , Greece
Investigational Site Number 3000004
Athens, , Greece
Investigational Site Number 3000002
Chalcis, , Greece
Investigational Site Number 3000009
Elefsina, , Greece
Investigational Site Number 3000003
Haidari, , Greece
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Heraklion, , Greece
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Ioannina, , Greece
Investigational Site Number 3000006
Larissa, , Greece
Investigational Site Number 3000001
N. Ionia, , Greece
Investigational Site Number 3000008
Thessaloniki, , Greece
Investigational Site Number 3480018
Berettyóújfalu, , Hungary
Investigational Site Number 3480012
Budapest, , Hungary
Investigational Site Number 3480016
Budapest, , Hungary
Investigational Site Number 3480010
Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
Investigational Site Number 3480014
Budapest, , Hungary
Investigational Site Number 3480005
Budapest, , Hungary
Investigational Site Number 3480007
Debrecen, , Hungary
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Dombóvár, , Hungary
Investigational Site Number 3480017
Gyula, , Hungary
Investigational Site Number 3480008
Hódmezövásárhely, , Hungary
Investigational Site Number 3480020
Kistarcsa, , Hungary
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Komárom, , Hungary
Investigational Site Number 3480013
Pécs, , Hungary
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Székesfehérvár, , Hungary
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Zalaegerszeg, , Hungary
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Ashkelon, , Israel
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Hadera, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
Investigational Site Number 3760011
Rehovot, , Israel
Investigational Site Number 3760009
Safed, , Israel
Investigational Site Number 3760001
Tel Aviv, , Israel
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Tiberias, , Israel
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Arzignano (Vi), , Italy
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Brescia, , Italy
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Brescia, , Italy
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Cortona, , Italy
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Ferrara, , Italy
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Gallipoli, , Italy
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Legnago, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Monza, , Italy
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Napoli, , Italy
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Pavia, , Italy
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Perugia, , Italy
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Pozzilli, , Italy
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Rimini, , Italy
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Roma, , Italy
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Roma, , Italy
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Scorrano, , Italy
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Udine, , Italy
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Daugavpils, , Latvia
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Liepāja, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Šiauliai, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Delft, , Netherlands
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Doetinchem, , Netherlands
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Rotterdam, , Netherlands
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Sneek, , Netherlands
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Veldhoven, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Hamilton, , New Zealand
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Lower Hutt, , New Zealand
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New Plymouth, , New Zealand
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Rotorua, , New Zealand
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Bialystok, , Poland
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Gdansk, , Poland
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Grodzisk Mazowiecki, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lubin, , Poland
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Miechów, , Poland
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Poznan, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Zamość, , Poland
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Łęczna, , Poland
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Braga, , Portugal
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Coimbra, , Portugal
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Guilhufe - Penafiel, , Portugal
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Guimarães, , Portugal
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Lisbon, , Portugal
Investigational Site Number 6200002
Lisbon, , Portugal
Investigational Site Number 6200008
Porto, , Portugal
Investigational Site Number 6200007
Vila Franca de Xira, , Portugal
Investigational Site Number 6200003
Vila Nova Gaia, , Portugal
Investigational Site Number 6200005
Vila Real, , Portugal
Investigational Site Number 6420014
Arad, , Romania
Investigational Site Number 6420006
Baia Mare, , Romania
Investigational Site Number 6420015
Brăila, , Romania
Investigational Site Number 6420013
Bucharest, , Romania
Investigational Site Number 6420019
Bucharest, , Romania
Investigational Site Number 6420011
Bucharest, , Romania
Investigational Site Number 6420008
Bucharest, , Romania
Investigational Site Number 6420007
Bucharest, , Romania
Investigational Site Number 6420002
Cluj-Napoca, , Romania
Investigational Site Number 6420003
Cluj-Napoca, , Romania
Investigational Site Number 6420016
Craiova, , Romania
Investigational Site Number 6420005
Oradea, , Romania
Investigational Site Number 6420004
Oradea, , Romania
Investigational Site Number 6420018
Satu Mare, , Romania
Investigational Site Number 6420001
Târgu Mureş, , Romania
Investigational Site Number 6420012
Tg-Mures, , Romania
Investigational Site Number 6420009
Timișoara, , Romania
Investigational Site Number 6420010
Timișoara, , Romania
Investigational Site Number 6430026
Ivanovo, , Russia
Investigational Site Number 6430023
Kazan', , Russia
Investigational Site Number 6430002
Kemerovo, , Russia
Investigational Site Number 6430006
Kemerovo, , Russia
Investigational Site Number 6430005
Moscow, , Russia
Investigational Site Number 6430004
Moscow, , Russia
Investigational Site Number 6430022
Moscow, , Russia
Investigational Site Number 6430024
Moscow, , Russia
Investigational Site Number 6430001
Moscow, , Russia
Investigational Site Number 6430003
Moscow, , Russia
Investigational Site Number 6430010
Moscow, , Russia
Investigational Site Number 6430018
Nizhny Novgorod, , Russia
Investigational Site Number 6430013
Rostov-on-Don, , Russia
Investigational Site Number 6430025
Saint Petersburg, , Russia
Investigational Site Number 6430007
Saint Petersburg, , Russia
Investigational Site Number 6430012
Saint Petersburg, , Russia
Investigational Site Number 6430011
Saint Petersburg, , Russia
Investigational Site Number 6430009
Saint Petersburg, , Russia
Investigational Site Number 6430017
Sochi, , Russia
Investigational Site Number 6430016
Tomsk, , Russia
Investigational Site Number 7030001
Bratislava, , Slovakia
Investigational Site Number 7030004
Bratislava, , Slovakia
Investigational Site Number 7030003
Bratislava 3 - Kramare, , Slovakia
Investigational Site Number 7030010
Brezno, , Slovakia
Investigational Site Number 7030009
Dolný Kubín, , Slovakia
Investigational Site Number 7030002
Košice, , Slovakia
Investigational Site Number 7030011
Nitra, , Slovakia
Investigational Site Number 7030008
Trnava, , Slovakia
Investigational Site Number 4100008
Bucheon-si, , South Korea
Investigational Site Number 4100010
Busan, , South Korea
Investigational Site Number 4100004
Daegu, , South Korea
Investigational Site Number 4100001
Hwaseong-si, , South Korea
Investigational Site Number 4100003
Incheon, , South Korea
Investigational Site Number 4100005
Seongnam-si, , South Korea
Investigational Site Number 4100002
Seoul, , South Korea
Investigational Site Number 4100007
Seoul, , South Korea
Investigational Site Number 4100011
Seoul, , South Korea
Investigational Site Number 4100009
Seoul, , South Korea
Investigational Site Number 7240006
A Coruña, , Spain
Investigational Site Number 7240016
Alicante, , Spain
Investigational Site Number 7240015
Badalona, , Spain
Investigational Site Number 7240020
L'Hospitalet de Llobregat, , Spain
Investigational Site Number 7240005
Las Palmas de Gran Canaria, , Spain
Investigational Site Number 7240021
Madrid, , Spain
Investigational Site Number 7240008
Madrid, , Spain
Investigational Site Number 7240022
Manises, , Spain
Investigational Site Number 7240004
Málaga, , Spain
Investigational Site Number 7240007
Murcia, , Spain
Investigational Site Number 7240014
Olot, , Spain
Investigational Site Number 7240009
San Sebastián de los Reyes, , Spain
Investigational Site Number 7240003
Sanlúcar de Barrameda, , Spain
Investigational Site Number 7240001
Seville, , Spain
Investigational Site Number 7240019
Seville, , Spain
Investigational Site Number 7240018
Úbeda, , Spain
Investigational Site Number 7240012
Valencia, , Spain
Investigational Site Number 7240011
Valencia, , Spain
Investigational Site Number 7240010
Valencia, , Spain
Investigational Site Number 7240002
Villamartín, , Spain
Investigational Site Number 7240013
Zaragoza, , Spain
Investigational Site Number 7520004
Jönköping, , Sweden
Investigational Site Number 7520002
Malmo, , Sweden
Investigational Site Number 7520006
Skellefteå, , Sweden
Investigational Site Number 7520007
Stockholm, , Sweden
Investigational Site Number 7520008
Stockholm, , Sweden
Investigational Site Number 7520001
Stockholm, , Sweden
Investigational Site Number 7560001
Basel, , Switzerland
Investigational Site Number 7560003
Lugano, , Switzerland
Investigational Site Number 7920008
Antalya, , Turkey (Türkiye)
Investigational Site Number 7920006
Çorum, , Turkey (Türkiye)
Investigational Site Number 7920005
Eskişehir, , Turkey (Türkiye)
Investigational Site Number 7920002
Haseki/ Istanbul, , Turkey (Türkiye)
Investigational Site Number 7920011
Istanbul, , Turkey (Türkiye)
Investigational Site Number 7920012
Izmir, , Turkey (Türkiye)
Investigational Site Number 7920003
Kocaeli, , Turkey (Türkiye)
Investigational Site Number 7920004
Mersin, , Turkey (Türkiye)
Investigational Site Number 7920001
Sivas, , Turkey (Türkiye)
Investigational Site Number 7920010
Trabzon, , Turkey (Türkiye)
Investigational Site Number 8260005
Bournemouth, , United Kingdom
Investigational Site Number 8260010
Bristol, , United Kingdom
Investigational Site Number 8260008
Chelmsford, , United Kingdom
Investigational Site Number 8260009
Hull, , United Kingdom
Investigational Site Number 8260002
Newcastle, , United Kingdom
Investigational Site Number 8260001
Oldham, , United Kingdom
Investigational Site Number 8260003
Swansea, , United Kingdom
Investigational Site Number 8260006
Swindon, , United Kingdom
Investigational Site Number 8260004
Torquay, , United Kingdom
Investigational Site Number 8260007
York, , United Kingdom
Countries
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References
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Bhatt AS, Bhatt DL, Steg PG, Szarek M, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Testani JM, Wilcox CS, Davies M, Pitt B, Kosiborod MN. Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF. J Am Coll Cardiol. 2024 Sep 17;84(12):1078-1088. doi: 10.1016/j.jacc.2024.06.036.
Weintraub WS, Kolm P, Dolman S, Alva M, Bhatt DL, Zhang Z. Cost-Effectiveness of Sotagliflozin in SOLOIST-WHF. JACC Heart Fail. 2024 Sep;12(9):1600-1610. doi: 10.1016/j.jchf.2024.04.018. Epub 2024 Jun 12.
Kim J, Wang S, Sikirica S, Shafrin J. Cost-effectiveness of sotagliflozin for the treatment of patients with diabetes and recent worsening heart failure. J Comp Eff Res. 2024 Jun;13(6):e230190. doi: 10.57264/cer-2023-0190. Epub 2024 May 21.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Szarek M, Bhatt DL, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Banks P, Tesfaye E, Ezekowitz JA, Verma S, Pitt B; SOLOIST-WHF committees and investigators. Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial. Ann Intern Med. 2021 Aug;174(8):1065-1072. doi: 10.7326/M21-0651. Epub 2021 Jun 22.
Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003510-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1190-7891
Identifier Type: OTHER
Identifier Source: secondary_id
EFC15156
Identifier Type: -
Identifier Source: org_study_id
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