Treatment of Diabetes in Patients With Systolic Heart Failure (NCT02920918) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline Aerobic Exercise Capacity at 12 Weeks
Timeframe: baseline and 12 weeks
2
Change From Baseline Ventilatory Efficiency at 12 Weeks