Treatment of Diabetes in Patients With Systolic Heart Failure

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Canagliflozin; Sitagliptin Phosphate

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.