Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03521934
Registration number
NCT03521934
Ethics application status
Date submitted
30/04/2018
Date registered
11/05/2018
Titles & IDs
Public title
Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Query!
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure
Query!
Secondary ID [1]
0
0
2017-003510-16
Query!
Secondary ID [2]
0
0
EFC15156
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Heart Failure
0
0
Query!
Type 2 Diabetes Mellitus
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Sotagliflozin
Treatment: Drugs - Placebo
Experimental: 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.
Placebo comparator: 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.
Treatment: Drugs: Sotagliflozin
Pharmaceutical form: tablet
Route of administration: oral
Treatment: Drugs: Placebo
Pharmaceutical form: tablet
Route of administration: oral
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
Query!
Assessment method [1]
0
0
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Query!
Timepoint [1]
0
0
Up to 21.9 months
Query!
Secondary outcome [1]
0
0
Total Number of Occurrences of HHF and Urgent HF Visits
Query!
Assessment method [1]
0
0
Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Query!
Timepoint [1]
0
0
Up to 21.9 months
Query!
Secondary outcome [2]
0
0
Total Number of Deaths From Cardiovascular Causes
Query!
Assessment method [2]
0
0
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Query!
Timepoint [2]
0
0
Up to 21.9 months
Query!
Secondary outcome [3]
0
0
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
Query!
Assessment method [3]
0
0
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Query!
Timepoint [3]
0
0
Up to 21.9 months
Query!
Secondary outcome [4]
0
0
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Query!
Assessment method [4]
0
0
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Query!
Timepoint [4]
0
0
Up to 21.9 months
Query!
Secondary outcome [5]
0
0
Total Number of Deaths From Any Cause
Query!
Assessment method [5]
0
0
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Query!
Timepoint [5]
0
0
Up to 21.9 months
Query!
Secondary outcome [6]
0
0
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4
Query!
Assessment method [6]
0
0
KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis.
Query!
Timepoint [6]
0
0
Baseline to Month 4
Query!
Secondary outcome [7]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Query!
Assessment method [7]
0
0
eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2). A mixed model for repeated measures (MMRM) was used for analysis.
Query!
Timepoint [7]
0
0
Baseline up to 21.9 months
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
* Type 2 Diabetes Mellitus.
* 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
* Age < 18 years or > 85 years.
* 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/06/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
5/06/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1222
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Investigational Site Number 0360007 - Murdoch
Query!
Recruitment hospital [2]
0
0
Investigational Site Number 0360001 - Wollongong
Query!
Recruitment postcode(s) [1]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [2]
0
0
2500 - Wollongong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Iowa
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Minnesota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Mississippi
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nebraska
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Mexico
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Ohio
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oregon
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Rhode Island
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
South Dakota
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Tennessee
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Texas
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Virginia
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
West Virginia
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Wisconsin
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Caba
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Capital Federal
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Ciudad De Buenos Aires
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Cordoba
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Corrientes
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Córdoba
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
La Plata
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
Merlo
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
Moron
Query!
Country [43]
0
0
Argentina
Query!
State/province [43]
0
0
Olivos
Query!
Country [44]
0
0
Argentina
Query!
State/province [44]
0
0
Quilmes
Query!
Country [45]
0
0
Argentina
Query!
State/province [45]
0
0
Rosario
Query!
Country [46]
0
0
Argentina
Query!
State/province [46]
0
0
Salta
Query!
Country [47]
0
0
Argentina
Query!
State/province [47]
0
0
San Martin
Query!
Country [48]
0
0
Argentina
Query!
State/province [48]
0
0
San Miguel De Tucuman
Query!
Country [49]
0
0
Argentina
Query!
State/province [49]
0
0
Santa Fe
Query!
Country [50]
0
0
Argentina
Query!
State/province [50]
0
0
Tucuman
Query!
Country [51]
0
0
Argentina
Query!
State/province [51]
0
0
Villa Belgrano
Query!
Country [52]
0
0
Argentina
Query!
State/province [52]
0
0
Villa Maria
Query!
Country [53]
0
0
Austria
Query!
State/province [53]
0
0
Braunau
Query!
Country [54]
0
0
Austria
Query!
State/province [54]
0
0
Feldkirch
Query!
Country [55]
0
0
Austria
Query!
State/province [55]
0
0
Graz
Query!
Country [56]
0
0
Austria
Query!
State/province [56]
0
0
Linz
Query!
Country [57]
0
0
Austria
Query!
State/province [57]
0
0
Salzburg
Query!
Country [58]
0
0
Austria
Query!
State/province [58]
0
0
Wien
Query!
Country [59]
0
0
Belgium
Query!
State/province [59]
0
0
Aalst
Query!
Country [60]
0
0
Belgium
Query!
State/province [60]
0
0
Gent
Query!
Country [61]
0
0
Belgium
Query!
State/province [61]
0
0
Kortrijk
Query!
Country [62]
0
0
Belgium
Query!
State/province [62]
0
0
Leuven
Query!
Country [63]
0
0
Belgium
Query!
State/province [63]
0
0
Liège
Query!
Country [64]
0
0
Belgium
Query!
State/province [64]
0
0
Mol
Query!
Country [65]
0
0
Belgium
Query!
State/province [65]
0
0
Mons
Query!
Country [66]
0
0
Belgium
Query!
State/province [66]
0
0
Roeselare
Query!
Country [67]
0
0
Brazil
Query!
State/province [67]
0
0
Belo Horizonte
Query!
Country [68]
0
0
Brazil
Query!
State/province [68]
0
0
Blumenau
Query!
Country [69]
0
0
Brazil
Query!
State/province [69]
0
0
Brasilia
Query!
Country [70]
0
0
Brazil
Query!
State/province [70]
0
0
Campinas
Query!
Country [71]
0
0
Brazil
Query!
State/province [71]
0
0
Fortaleza
Query!
Country [72]
0
0
Brazil
Query!
State/province [72]
0
0
Goiania
Query!
Country [73]
0
0
Brazil
Query!
State/province [73]
0
0
Passo Fundo
Query!
Country [74]
0
0
Brazil
Query!
State/province [74]
0
0
Porto Alegre
Query!
Country [75]
0
0
Brazil
Query!
State/province [75]
0
0
Recife
Query!
Country [76]
0
0
Brazil
Query!
State/province [76]
0
0
Sao Jose Do Rio Preto
Query!
Country [77]
0
0
Brazil
Query!
State/province [77]
0
0
Sao Paulo
Query!
Country [78]
0
0
Brazil
Query!
State/province [78]
0
0
Votuporanga
Query!
Country [79]
0
0
Canada
Query!
State/province [79]
0
0
Cambridge
Query!
Country [80]
0
0
Canada
Query!
State/province [80]
0
0
Granby
Query!
Country [81]
0
0
Canada
Query!
State/province [81]
0
0
Halifax
Query!
Country [82]
0
0
Canada
Query!
State/province [82]
0
0
Montreal
Query!
Country [83]
0
0
Canada
Query!
State/province [83]
0
0
Peterborough
Query!
Country [84]
0
0
Canada
Query!
State/province [84]
0
0
Quebec
Query!
Country [85]
0
0
Canada
Query!
State/province [85]
0
0
Scarborough
Query!
Country [86]
0
0
Canada
Query!
State/province [86]
0
0
Sherbrooke
Query!
Country [87]
0
0
Canada
Query!
State/province [87]
0
0
Toronto
Query!
Country [88]
0
0
Canada
Query!
State/province [88]
0
0
Trois-Rivières
Query!
Country [89]
0
0
Chile
Query!
State/province [89]
0
0
Concepción
Query!
Country [90]
0
0
Chile
Query!
State/province [90]
0
0
Santiago
Query!
Country [91]
0
0
Chile
Query!
State/province [91]
0
0
Temuco
Query!
Country [92]
0
0
Chile
Query!
State/province [92]
0
0
Vina Del Mar
Query!
Country [93]
0
0
Chile
Query!
State/province [93]
0
0
Viña Del Mar
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Brno
Query!
Country [95]
0
0
Czechia
Query!
State/province [95]
0
0
Kolin 3
Query!
Country [96]
0
0
Czechia
Query!
State/province [96]
0
0
Kromeriz
Query!
Country [97]
0
0
Czechia
Query!
State/province [97]
0
0
Liberec
Query!
Country [98]
0
0
Czechia
Query!
State/province [98]
0
0
Mestec Kralove
Query!
Country [99]
0
0
Czechia
Query!
State/province [99]
0
0
Praha 10
Query!
Country [100]
0
0
Czechia
Query!
State/province [100]
0
0
Praha 2
Query!
Country [101]
0
0
Czechia
Query!
State/province [101]
0
0
Praha 5 - Motol
Query!
Country [102]
0
0
Czechia
Query!
State/province [102]
0
0
Praha 5
Query!
Country [103]
0
0
Czechia
Query!
State/province [103]
0
0
Prerov
Query!
Country [104]
0
0
Czechia
Query!
State/province [104]
0
0
Pribram I
Query!
Country [105]
0
0
Czechia
Query!
State/province [105]
0
0
Slany
Query!
Country [106]
0
0
Denmark
Query!
State/province [106]
0
0
Aarhus N
Query!
Country [107]
0
0
Denmark
Query!
State/province [107]
0
0
Glostrup
Query!
Country [108]
0
0
Denmark
Query!
State/province [108]
0
0
Herlev
Query!
Country [109]
0
0
Denmark
Query!
State/province [109]
0
0
København Nv
Query!
Country [110]
0
0
Denmark
Query!
State/province [110]
0
0
Ålborg
Query!
Country [111]
0
0
Finland
Query!
State/province [111]
0
0
Espoo
Query!
Country [112]
0
0
Finland
Query!
State/province [112]
0
0
Helsinki
Query!
Country [113]
0
0
Finland
Query!
State/province [113]
0
0
Jyväskylä
Query!
Country [114]
0
0
Finland
Query!
State/province [114]
0
0
Oulu
Query!
Country [115]
0
0
Finland
Query!
State/province [115]
0
0
Seinäjoki
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Chambray Les Tours
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
La Tronche
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Le Chesnay
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Le Coudray
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Lille
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Nantes Cedex 1
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Nice Cedex 1
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Paris Cedex 18
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Paris
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Toulouse Cedex 9
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Vandoeuvre-Les-Nancy Cedex
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Bad Nauheim
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Bad Oeynhausen
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Berlin
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Bielefeld
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Bonn
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Bremen
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Coburg
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Dortmund
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Erfurt
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Essen
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Frankfurt Am Main
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Greifswald
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Heidelberg
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Köln
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Lahr
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Langen
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Leverkusen
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Limburg
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Ludwigshafen
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Merseburg
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Rotenburg An Der Fulda
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Rüsselsheim
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Witten
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Würzburg
Query!
Country [151]
0
0
Greece
Query!
State/province [151]
0
0
Athens
Query!
Country [152]
0
0
Greece
Query!
State/province [152]
0
0
Chalkida
Query!
Country [153]
0
0
Greece
Query!
State/province [153]
0
0
Elefsina
Query!
Country [154]
0
0
Greece
Query!
State/province [154]
0
0
Haidari
Query!
Country [155]
0
0
Greece
Query!
State/province [155]
0
0
Heraklion
Query!
Country [156]
0
0
Greece
Query!
State/province [156]
0
0
Ioannina
Query!
Country [157]
0
0
Greece
Query!
State/province [157]
0
0
Larissa
Query!
Country [158]
0
0
Greece
Query!
State/province [158]
0
0
N. Ionia
Query!
Country [159]
0
0
Greece
Query!
State/province [159]
0
0
Thessaloniki
Query!
Country [160]
0
0
Hungary
Query!
State/province [160]
0
0
Berettyóújfalu
Query!
Country [161]
0
0
Hungary
Query!
State/province [161]
0
0
Budapest
Query!
Country [162]
0
0
Hungary
Query!
State/province [162]
0
0
Debrecen
Query!
Country [163]
0
0
Hungary
Query!
State/province [163]
0
0
Dombóvár
Query!
Country [164]
0
0
Hungary
Query!
State/province [164]
0
0
Gyula
Query!
Country [165]
0
0
Hungary
Query!
State/province [165]
0
0
Hódmezövásárhely
Query!
Country [166]
0
0
Hungary
Query!
State/province [166]
0
0
Kistarcsa
Query!
Country [167]
0
0
Hungary
Query!
State/province [167]
0
0
Komárom
Query!
Country [168]
0
0
Hungary
Query!
State/province [168]
0
0
Pécs
Query!
Country [169]
0
0
Hungary
Query!
State/province [169]
0
0
Szekesfehervar
Query!
Country [170]
0
0
Hungary
Query!
State/province [170]
0
0
Zalaegerszeg
Query!
Country [171]
0
0
Israel
Query!
State/province [171]
0
0
Ashkelon
Query!
Country [172]
0
0
Israel
Query!
State/province [172]
0
0
Hadera
Query!
Country [173]
0
0
Israel
Query!
State/province [173]
0
0
Haifa
Query!
Country [174]
0
0
Israel
Query!
State/province [174]
0
0
Jerusalem
Query!
Country [175]
0
0
Israel
Query!
State/province [175]
0
0
Nahariya
Query!
Country [176]
0
0
Israel
Query!
State/province [176]
0
0
Petah-Tikva
Query!
Country [177]
0
0
Israel
Query!
State/province [177]
0
0
Rehovot
Query!
Country [178]
0
0
Israel
Query!
State/province [178]
0
0
Safed
Query!
Country [179]
0
0
Israel
Query!
State/province [179]
0
0
Tel Aviv
Query!
Country [180]
0
0
Israel
Query!
State/province [180]
0
0
Tiberias
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Arzignano (Vi)
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Brescia
Query!
Country [183]
0
0
Italy
Query!
State/province [183]
0
0
Cortona
Query!
Country [184]
0
0
Italy
Query!
State/province [184]
0
0
Ferrara
Query!
Country [185]
0
0
Italy
Query!
State/province [185]
0
0
Gallipoli
Query!
Country [186]
0
0
Italy
Query!
State/province [186]
0
0
Legnago
Query!
Country [187]
0
0
Italy
Query!
State/province [187]
0
0
Milano
Query!
Country [188]
0
0
Italy
Query!
State/province [188]
0
0
Monza
Query!
Country [189]
0
0
Italy
Query!
State/province [189]
0
0
Napoli
Query!
Country [190]
0
0
Italy
Query!
State/province [190]
0
0
Pavia
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Perugia
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Pozzilli
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Rimini
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Roma
Query!
Country [195]
0
0
Italy
Query!
State/province [195]
0
0
Scorrano
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Udine
Query!
Country [197]
0
0
Korea, Republic of
Query!
State/province [197]
0
0
Bucheon-Si
Query!
Country [198]
0
0
Korea, Republic of
Query!
State/province [198]
0
0
Busan
Query!
Country [199]
0
0
Korea, Republic of
Query!
State/province [199]
0
0
Daegu
Query!
Country [200]
0
0
Korea, Republic of
Query!
State/province [200]
0
0
Hwaseong-Si
Query!
Country [201]
0
0
Korea, Republic of
Query!
State/province [201]
0
0
Incheon
Query!
Country [202]
0
0
Korea, Republic of
Query!
State/province [202]
0
0
Seongnam-Si
Query!
Country [203]
0
0
Korea, Republic of
Query!
State/province [203]
0
0
Seoul
Query!
Country [204]
0
0
Latvia
Query!
State/province [204]
0
0
Daugavpils
Query!
Country [205]
0
0
Latvia
Query!
State/province [205]
0
0
Liepaja
Query!
Country [206]
0
0
Latvia
Query!
State/province [206]
0
0
Riga
Query!
Country [207]
0
0
Lithuania
Query!
State/province [207]
0
0
Kaunas
Query!
Country [208]
0
0
Lithuania
Query!
State/province [208]
0
0
Klaipeda
Query!
Country [209]
0
0
Lithuania
Query!
State/province [209]
0
0
Siauliai
Query!
Country [210]
0
0
Lithuania
Query!
State/province [210]
0
0
Vilnius
Query!
Country [211]
0
0
Netherlands
Query!
State/province [211]
0
0
Amsterdam
Query!
Country [212]
0
0
Netherlands
Query!
State/province [212]
0
0
Breda
Query!
Country [213]
0
0
Netherlands
Query!
State/province [213]
0
0
Delft
Query!
Country [214]
0
0
Netherlands
Query!
State/province [214]
0
0
Doetinchem
Query!
Country [215]
0
0
Netherlands
Query!
State/province [215]
0
0
Hertogenbosch
Query!
Country [216]
0
0
Netherlands
Query!
State/province [216]
0
0
Rotterdam
Query!
Country [217]
0
0
Netherlands
Query!
State/province [217]
0
0
Sneek
Query!
Country [218]
0
0
Netherlands
Query!
State/province [218]
0
0
Veldhoven
Query!
Country [219]
0
0
New Zealand
Query!
State/province [219]
0
0
Auckland
Query!
Country [220]
0
0
New Zealand
Query!
State/province [220]
0
0
Christchurch
Query!
Country [221]
0
0
New Zealand
Query!
State/province [221]
0
0
Hamilton
Query!
Country [222]
0
0
New Zealand
Query!
State/province [222]
0
0
Lower Hutt
Query!
Country [223]
0
0
New Zealand
Query!
State/province [223]
0
0
New Plymouth
Query!
Country [224]
0
0
New Zealand
Query!
State/province [224]
0
0
Rotorua
Query!
Country [225]
0
0
Poland
Query!
State/province [225]
0
0
Bialystok
Query!
Country [226]
0
0
Poland
Query!
State/province [226]
0
0
Gdansk
Query!
Country [227]
0
0
Poland
Query!
State/province [227]
0
0
Grodzisk Mazowiecki
Query!
Country [228]
0
0
Poland
Query!
State/province [228]
0
0
Katowice
Query!
Country [229]
0
0
Poland
Query!
State/province [229]
0
0
Krakow
Query!
Country [230]
0
0
Poland
Query!
State/province [230]
0
0
Leczna
Query!
Country [231]
0
0
Poland
Query!
State/province [231]
0
0
Lubin
Query!
Country [232]
0
0
Poland
Query!
State/province [232]
0
0
Miechow
Query!
Country [233]
0
0
Poland
Query!
State/province [233]
0
0
Poznan
Query!
Country [234]
0
0
Poland
Query!
State/province [234]
0
0
Torun
Query!
Country [235]
0
0
Poland
Query!
State/province [235]
0
0
Warszawa
Query!
Country [236]
0
0
Poland
Query!
State/province [236]
0
0
Zamosc
Query!
Country [237]
0
0
Portugal
Query!
State/province [237]
0
0
Braga
Query!
Country [238]
0
0
Portugal
Query!
State/province [238]
0
0
Coimbra
Query!
Country [239]
0
0
Portugal
Query!
State/province [239]
0
0
Guilhufe - Penafiel
Query!
Country [240]
0
0
Portugal
Query!
State/province [240]
0
0
Guimarães
Query!
Country [241]
0
0
Portugal
Query!
State/province [241]
0
0
Lisboa
Query!
Country [242]
0
0
Portugal
Query!
State/province [242]
0
0
Porto
Query!
Country [243]
0
0
Portugal
Query!
State/province [243]
0
0
Vila Franca De Xira
Query!
Country [244]
0
0
Portugal
Query!
State/province [244]
0
0
Vila Nova Gaia
Query!
Country [245]
0
0
Portugal
Query!
State/province [245]
0
0
Vila Real
Query!
Country [246]
0
0
Romania
Query!
State/province [246]
0
0
Arad
Query!
Country [247]
0
0
Romania
Query!
State/province [247]
0
0
Baia Mare
Query!
Country [248]
0
0
Romania
Query!
State/province [248]
0
0
Braila
Query!
Country [249]
0
0
Romania
Query!
State/province [249]
0
0
Bucharest
Query!
Country [250]
0
0
Romania
Query!
State/province [250]
0
0
Bucuresti
Query!
Country [251]
0
0
Romania
Query!
State/province [251]
0
0
Cluj Napoca
Query!
Country [252]
0
0
Romania
Query!
State/province [252]
0
0
Craiova
Query!
Country [253]
0
0
Romania
Query!
State/province [253]
0
0
Oradea
Query!
Country [254]
0
0
Romania
Query!
State/province [254]
0
0
Satu Mare
Query!
Country [255]
0
0
Romania
Query!
State/province [255]
0
0
Targu Mures
Query!
Country [256]
0
0
Romania
Query!
State/province [256]
0
0
Tg-Mures
Query!
Country [257]
0
0
Romania
Query!
State/province [257]
0
0
Timisoara
Query!
Country [258]
0
0
Russian Federation
Query!
State/province [258]
0
0
Ivanovo
Query!
Country [259]
0
0
Russian Federation
Query!
State/province [259]
0
0
Kazan
Query!
Country [260]
0
0
Russian Federation
Query!
State/province [260]
0
0
Kemerovo
Query!
Country [261]
0
0
Russian Federation
Query!
State/province [261]
0
0
Moscow
Query!
Country [262]
0
0
Russian Federation
Query!
State/province [262]
0
0
Nizhniy Novgorod
Query!
Country [263]
0
0
Russian Federation
Query!
State/province [263]
0
0
Rostov-Na-Donu
Query!
Country [264]
0
0
Russian Federation
Query!
State/province [264]
0
0
Saint-Petersburg
Query!
Country [265]
0
0
Russian Federation
Query!
State/province [265]
0
0
Sochi
Query!
Country [266]
0
0
Russian Federation
Query!
State/province [266]
0
0
St-Petersburg
Query!
Country [267]
0
0
Russian Federation
Query!
State/province [267]
0
0
Tomsk
Query!
Country [268]
0
0
Slovakia
Query!
State/province [268]
0
0
Bratislava 3 - Kramare
Query!
Country [269]
0
0
Slovakia
Query!
State/province [269]
0
0
Bratislava 37
Query!
Country [270]
0
0
Slovakia
Query!
State/province [270]
0
0
Bratislava
Query!
Country [271]
0
0
Slovakia
Query!
State/province [271]
0
0
Brezno
Query!
Country [272]
0
0
Slovakia
Query!
State/province [272]
0
0
Dolny Kubin
Query!
Country [273]
0
0
Slovakia
Query!
State/province [273]
0
0
Kosice
Query!
Country [274]
0
0
Slovakia
Query!
State/province [274]
0
0
Nitra
Query!
Country [275]
0
0
Slovakia
Query!
State/province [275]
0
0
Trnava
Query!
Country [276]
0
0
Spain
Query!
State/province [276]
0
0
Alicante
Query!
Country [277]
0
0
Spain
Query!
State/province [277]
0
0
Badalona
Query!
Country [278]
0
0
Spain
Query!
State/province [278]
0
0
Hospitalet De Llobregat
Query!
Country [279]
0
0
Spain
Query!
State/province [279]
0
0
La Coruña
Query!
Country [280]
0
0
Spain
Query!
State/province [280]
0
0
Las Palmas De Gran Canaria
Query!
Country [281]
0
0
Spain
Query!
State/province [281]
0
0
Madrid
Query!
Country [282]
0
0
Spain
Query!
State/province [282]
0
0
Manises
Query!
Country [283]
0
0
Spain
Query!
State/province [283]
0
0
Murcia
Query!
Country [284]
0
0
Spain
Query!
State/province [284]
0
0
Málaga
Query!
Country [285]
0
0
Spain
Query!
State/province [285]
0
0
Olot
Query!
Country [286]
0
0
Spain
Query!
State/province [286]
0
0
San Sebastián De Los Reyes
Query!
Country [287]
0
0
Spain
Query!
State/province [287]
0
0
Sanlúcar De Barrameda
Query!
Country [288]
0
0
Spain
Query!
State/province [288]
0
0
Sevilla
Query!
Country [289]
0
0
Spain
Query!
State/province [289]
0
0
Valencia
Query!
Country [290]
0
0
Spain
Query!
State/province [290]
0
0
Villamartín
Query!
Country [291]
0
0
Spain
Query!
State/province [291]
0
0
Zaragoza
Query!
Country [292]
0
0
Spain
Query!
State/province [292]
0
0
Úbeda
Query!
Country [293]
0
0
Sweden
Query!
State/province [293]
0
0
Jönköping
Query!
Country [294]
0
0
Sweden
Query!
State/province [294]
0
0
Malmö
Query!
Country [295]
0
0
Sweden
Query!
State/province [295]
0
0
Skellefteå
Query!
Country [296]
0
0
Sweden
Query!
State/province [296]
0
0
Stockholm
Query!
Country [297]
0
0
Switzerland
Query!
State/province [297]
0
0
Basel
Query!
Country [298]
0
0
Switzerland
Query!
State/province [298]
0
0
Lugano
Query!
Country [299]
0
0
Turkey
Query!
State/province [299]
0
0
Antalya
Query!
Country [300]
0
0
Turkey
Query!
State/province [300]
0
0
Corum
Query!
Country [301]
0
0
Turkey
Query!
State/province [301]
0
0
Eskisehir
Query!
Country [302]
0
0
Turkey
Query!
State/province [302]
0
0
Haseki/ Istanbul
Query!
Country [303]
0
0
Turkey
Query!
State/province [303]
0
0
Istanbul
Query!
Country [304]
0
0
Turkey
Query!
State/province [304]
0
0
Izmir
Query!
Country [305]
0
0
Turkey
Query!
State/province [305]
0
0
Kocaeli
Query!
Country [306]
0
0
Turkey
Query!
State/province [306]
0
0
Mersin
Query!
Country [307]
0
0
Turkey
Query!
State/province [307]
0
0
Sivas
Query!
Country [308]
0
0
Turkey
Query!
State/province [308]
0
0
Trabzon
Query!
Country [309]
0
0
United Kingdom
Query!
State/province [309]
0
0
Bournemouth
Query!
Country [310]
0
0
United Kingdom
Query!
State/province [310]
0
0
Bristol
Query!
Country [311]
0
0
United Kingdom
Query!
State/province [311]
0
0
Chelmsford
Query!
Country [312]
0
0
United Kingdom
Query!
State/province [312]
0
0
Hull
Query!
Country [313]
0
0
United Kingdom
Query!
State/province [313]
0
0
Newcastle
Query!
Country [314]
0
0
United Kingdom
Query!
State/province [314]
0
0
Oldham
Query!
Country [315]
0
0
United Kingdom
Query!
State/province [315]
0
0
Swansea
Query!
Country [316]
0
0
United Kingdom
Query!
State/province [316]
0
0
Swindon
Query!
Country [317]
0
0
United Kingdom
Query!
State/province [317]
0
0
Torquay
Query!
Country [318]
0
0
United Kingdom
Query!
State/province [318]
0
0
York
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Lexicon Pharmaceuticals
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Sanofi
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Primary Objective: 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)
Query!
Trial website
https://clinicaltrials.gov/study/NCT03521934
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Suman Wason, MD
Query!
Address
0
0
Lexicon Pharmaceuticals, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/34/NCT03521934/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/34/NCT03521934/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03521934