Trials / Withdrawn
WithdrawnNCT03298009
Impact of a Short-term Treatment With Canagliflozin (Canacardia-HF)
Subclinical Inflammation, Myocardial Function and Fatty Acid Metabolism in Patients With Type 2 Diabetes and Heart Failure: Impact of a Short-term Treatment With Canagliflozin - a Pilot Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Université de Sherbrooke · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
It is a mechanistic proof-of-concept study to demonstrate how SGLT-2 inhibitors (Canagliflozin) may have a beneficial role on cardiac energetic efficiency. Patients with type 2 diabetes and with HF diagnosed for at least 3 months will be selected. The participants will be randomized to a double-blind, crossover 2-week placebo vs. Cana 100 mg once daily, an interventional trial with a one-month washout period in between. At the term of the two-week placebo and canagliflozin treatment periods (visits 2 and 4), each participant will undergo an identical postprandial metabolic study with positron emission tomography (PET) and stable isotopic tracer methods.
Detailed description
Non-invasive Positron Emission Tomography (PET) imaging method allows to measure myocardial uptake and organ-specific partitioning of dietary fatty acids (DFA). It allows to study kidney, liver, skeletal muscles and adipose tissues DFA utilization, whole body fatty acid turnover and oxidation rates, myocardial oxidative metabolism and left ventricular (LV) function that are other likely targets of SGLT-2 inhibitors. Thus, the PET is ideal to verify the very interesting hypothesis that, increase in liver fatty acid utilization and/or adipose tissue dietary fatty acid uptake, may lead to reduced cardiac utilization of fatty acids and improved cardiac energetic efficiency. .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Canagliflozin 100mg | 2-week intervention |
| DRUG | Placebo oral capsule | 2-week intervention |
| RADIATION | PET imaging | 1 day postprandial metabolic protocol at the end of treatment: CT scan followed by dynamic and pancorporel imaging |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2018-06-30
- Completion
- 2018-06-30
- First posted
- 2017-09-29
- Last updated
- 2024-12-13
Source: ClinicalTrials.gov record NCT03298009. Inclusion in this directory is not an endorsement.