Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lexicon Pharmaceuticals
With
Sanofi
The estimated study duration for a given participants will be approximately 3 to 24 months.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
