CompletedPhase 4

Treatment of Diabetes in Patients With Systolic Heart Failure

United States36 participantsStarted 2016-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 fo…

What they're measuring

Change From Baseline Aerobic Exercise Capacity at 12 Weeks

Timeframe: baseline and 12 weeks

Change From Baseline Ventilatory Efficiency at 12 Weeks

Timeframe: baseline and 12 weeks

Trial details

NCT IDNCT02920918

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

Results submitted2019-09-23