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

  • Interventional
  • Recruiting
  • NCT03521934
Eligibility Details Visit Clinicaltrials.gov

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

Primary Objective: - To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF) with left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart failure (WHF). - To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with T2D and HF irrespective of LVEF after admission for WHF. Secondary Objectives: - To demonstrate that, when compared to placebo in the toal patient population, sotagliflozin reduces the total number (i.e., including recurrent events) of the following clinical events: - Cardiovascular death, HHF or urgent HF visit. - To demonstrate that, when compared to placebo, sotagliflozin reduces: - The composite of positively adjudicated sustained ≥50% decrease in eGFR, chronic dialysis, renal transplant or positively adjudicated sustained eGFR <15 mL/min/1.73 m2 in the total patient population. - Cardiovascular death in patients with LVEF < 50%. - Cardiovascular death in the total patient population. - All-cause mortality in patients with LVEF < 50%. - All cause mortality in the total patient population. - To demonstrate the safety and tolerability of sotagliflozin in the total population in this study.

The estimated study duration for a given patient will be approximately 3 to 32 months.

Gender
All

Age Group
18 Years to 85 Years

Accepting Healthy Volunteers?
No

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 pg/mL (≥450 pg/mL for patients with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for patients with atrial fibrillation).

         - Patients 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 patient'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 mL/min/1.73 m².

         - Pregnancy.

        The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

At a Glance

National Government IDNCT03521934

IRB#IRB18-0992

Lead SponsorSanofi

Lead PhysicianSara Kalantari

Collaborator(s)N/A

EligibilityAll
18 Years to 85 Years
Recruiting