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Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) | Clinical Trials | Clareo Health

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Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

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

NCT03521934•Lexicon Pharmaceuticals

View on ClinicalTrials.gov

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)

Detailed Description

The estimated study duration for a given participants will be approximately 3 to 24 months.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.

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.
+6 more criteria

Locations (466)

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

Key Dates

Start Date

June 15, 2018

Primary Completion Date

June 5, 2020

Completion Date

June 5, 2020

Last Updated

October 28, 2022

Enrollment

1,222

ACTUAL participants

Conditions

Heart FailureType 2 Diabetes Mellitus

Interventions

Sotagliflozin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Inclusion Criteria

Exclusion Criteria

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