Treatment of Diabetes in Patients With Systolic Heart Failure
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|ClinicalTrials.gov Identifier: NCT02920918|
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Systolic Diabetes Mellitus, Type 2||Drug: Canagliflozin Drug: Sitagliptin||Phase 4|
Investigator Initiated Study: Randomized, double-blinded, active-control clinical trial to determine the safety and efficacy of Canagliflozin and Sitagliptin in patients with type 2 diabetes and systolic heart failure (HF).
The investigators propose to study the effects of Canagliflozin 100 mg vs Sitagliptin 100 mg (both administered once daily for 12 weeks) on parameters of aerobic exercise capacity and ventilator efficiency by CPET after 12 weeks of active treatment. BP, body water content (Bioelectrical Impedance Analysis [BIA]), body composition (Dual-energy X-ray absorptiometry [DEXA]), cardiac function, diet and biomarkers will be also measured. Subjects with evidence of left ventricular hypertrophy will undergo cardiac magnetic resonance (CMR) imaging.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Active Comparator: Canagliflozin
Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.
Other Name: Invokana
Active Comparator: Sitagliptin
Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.
Other Name: Januvia
- Change from baseline aerobic exercise capacity at 12 weeks [ Time Frame: baseline and 12 weeks ]measured by cardiopulmonary exercise test
- Change from baseline ventilator efficiency at 12 weeks [ Time Frame: baseline and 12 weeks ]measured by cardiopulmonary exercise test
- blood pressure [ Time Frame: baseline, 4, 8 and 12 weeks ]
- body water content [ Time Frame: baseline, 4, 8 and 12 weeks ]measured using bioelectrical impedance analysis (BIA)
- body composition [ Time Frame: baseline and 12 weeks ]measured using dual-energy x-ray absorptiometry (DEXA)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920918
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Antonio Abbate, MD, PhD||Virginia Commonwealth University|