NCT02920918|CompletedPhase 4Results
Treatment of Diabetes in Patients With Systolic Heart Failure
A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Janssen Scientific Affairs
interventional
36
1 country
1
Study Start
October 2016
Actual (reported)Primary Completion
September 2018
Actual (reported)Study Completion
September 2018
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2016
Actual (reported)September 30, 2016
Actual (reported)October 2016
Actual (reported)September 2018
Actual (reported)September 2018
Actual (reported)October 29, 2019
Actual (reported)Change From Baseline Aerobic Exercise Capacity at 12 Weeks
Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test
baseline and 12 weeks
Change From Baseline Ventilatory Efficiency at 12 Weeks
Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test
baseline and 12 weeks
Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.
Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Antonio Abbate, MD, PhD
Virginia Commonwealth University
36 participants (actual enrollment reported by the registry).
First Submitted
September 22, 2016
First Posted
September 30, 2016
Study Start
October 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 2018
Actual (reported)Study Completion
September 2018
Actual (reported)Last Updated
October 29, 2019
Results First Posted
October 29, 2019
Record last verified: 2019-10
The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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