Treatment of Diabetes in Patients With Systolic Heart Failure
Condition: Heart Failure, Systolic; Diabetes Mellitus, Type 2
MeSH terms: Heart Failure; Heart Failure, Systolic; Diabetes Mellitus; Diabetes Mellitus, Type 2; Systolic Murmurs
Intervention: Canagliflozin; Sitagliptin
Intervention MeSH terms: Sitagliptin Phosphate; Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systolic Heart Failure; Canagliflozin; Sitagliptin Phosphate; Type 2 Diabetes; SGLT2 inhibitor; DPPIV inhibitor

Summary:

      Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs
      Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption [VO2])
      and ventilator efficiency (minute ventilation [VE]/carbon dioxide production [VCO2] slope) at
      cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary endpoints).
      Blood pressure (BP), body water content, body composition, cardiac function, and diet will be
      also measured (secondary endpoints).
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Symptomatic stable heart failure (New York Heart Association (NYHA) functional
             classification II-III) with reduced left ventricular ejection fraction (LVEF) ≤40%

          -  Peak exercise limited by shortness of breath and associated with a respiratory
             exchange ratio (RER) >1.00 (reflecting maximal aerobic effort);

          -  Poorly controlled Type 2 Diabetes Mellitus (T2DM)(HbA1c levels between 7.0% and 10.0%
             if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an
             insulin regimen);

          -  Eighteen years of age or older.

        Major Exclusion Criteria:

          -  Type I diabetes;

          -  Open label treatment with Sodium-GLucose coTransporter (SGLT)-2 inhibitors (within the
             past 3 months);

          -  Current treatment with thiazolidinedione (within the past 3 months);

          -  Chronic Renal Disease defined as Glomerular Filtration Rate (GFR) <50 ml•min-1/1.73m2
             according to local laboratory

          -  Pregnancy or of child-bearing potential or lactating;

          -  Active or recent (within 2 weeks) genital/urinary infection;

          -  Concomitant conditions or treatment which would affect completion or interpretation of
             the study (i.e, physical inability to walk or run on a treadmill

          -  Inability to give informed consent.

        Exclusion criteria specific to the cardiac magnetic resonance (CMR) substudy.

          -  Estimated GFR <60 ml•min-1/1.73m2

          -  Implantable cardioverter defibrillator, pacemaker or other implantable metal device
             not compatible with CMR scanning;

          -  Severe claustrophobia, inability to lay flat for up to 60 minutes, or other
             contraindication to CMR scanning.