Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) | NCT03521934 | Trialant

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) | NCT03521934 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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.

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.