Clinical Trial: Treatment of Diabetes in Patients With Systolic Heart Failure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure

Brief 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).

Detailed Summary:

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.

Sponsor: Virginia Commonwealth University

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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)

Original Secondary Outcome: Same as current

Information By: Virginia Commonwealth University

Dates:
Date Received: September 22, 2016
Date Started: October 2016
Date Completion: November 2018
Last Updated: November 10, 2016
Last Verified: November 2016