Type2 DiabetesCanacardiaNCT03298009
Impact of a Short-term Treatment With Canagliflozin (Canacardia-HF)
A study testing Canagliflozin 100mg and PET imaging in people with Type2 Diabetes and Heart Failure, run by Université de Sherbrooke.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes, Heart Failure
- What is being tested?
- Canagliflozin 100mg and PET imaging
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c 7.5 -10.5%;
- LVEF < 40%;
- NYHA class 2 or 3;
- NT pro-BNP level > 600 pg/mL;
- Being on a stable-dose metformin therapy max 2500 mg/day or other hypoglycemic therapy and RAAS-blocking agents for at least 8 weeks;
- Being on optimal and stable-doses of heart failure medication including diuretics for at least 4 weeks;
Who cannot join
- age <18 yo;
- NYHA class 4;
- Treatment with a fibrate or thiazolidinedione;
- Unstable or advanced renal failure;
- Unstable or new medical or surgical condition within the past 3 months;
- Heart failure caused by active inflammatory condition such as sarcoidosis or any form of myocarditis;
Show all 17Show fewer
- History of diabetic ketoacidosis;
- Not on a stable regimen for at least 8 weeks before the screening visit;
- Female of child-bearing potential who is pregnant, breast feeding or intends to become pregnant or pre-menopausal female with a positive serum pregnancy test at the time of enrollment;
- Patients post bariatric surgery, or on weight loss medication;
- Contraindications to metformin, including allergy or intolerance;
- Hospitalization for heart failure within the 60 days prior to enrollment;
- Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within the 60 days prior to enrollment;
- Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy) within the 90 days after enrollment;
- Patients who are volume depleted based upon physical examination at the time of enrollment;
- Chronic disabling illness;
- History of substance abuse.
About this study
Official title: 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
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.
Read the 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
- Type2 Diabetes, Heart Failure
- Being tested
- Canagliflozin 100mg, Placebo oral capsule, PET imaging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin 100mgDrug
Also called Invokana
2-week intervention
Placebo oral capsuleDrug
2-week intervention
PET imagingRadiation
1 day postprandial metabolic protocol at the end of treatment: CT scan followed by dynamic and pancorporel imaging
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Placebo comparator | placebo oral capsule will be administered once daily, for 2 weeks Receives: Drug: Placebo oral capsule; Radiation: PET imaging |
| Treatment 2 | Experimental | Canagliflozine 100mg once daily, for 2 weeks Receives: Drug: Canagliflozin 100mg; Radiation: PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change to be observed with canagliflozin on myocardial dietary fatty acid uptake
will be assessed using oral administration of 18-fluoro-thiaheptadecanoic acid ([18F]-FTHA) with sequential dynamic.
PET/CT scanning.
Measured: 3 months
Change to be observed with canagliflozin on whole-body partitioning.
will be assessed using oral administration of 18-fluoro-thiaheptadecanoic acid ([18F]-FTHA, with static PET/CT scanning
Measured: 3 months
Secondary outcomes (3)
myocardial and liver NEFA uptake
using PET with [11C]-palmitate
Measured: 3 months
NEFA oxidative rate
using PET with [11C]-acetate
Measured: 3 months
plasma NEFA turnover
using i.v. infusion of [U-13C]-palmitate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 May 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: end of contract negociations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled, double-blind, randomized crossover 2-week intervention study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Principal investigator, André Carpentier, Université de Sherbrooke
- Investigators
- André C. Carpentier, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298009
- Sponsor's protocol ID
- 28431754DIA4029
- Acronym
- Canacardia
- Status last verified
- Dec 2024
- First submitted
- 26 Sep 2017
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03298009
- Acronym / sponsor ID
- Canacardia / 28431754DIA4029
- Conditions
- Type2 Diabetes, Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: end of contract negociations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled, double-blind, randomized crossover 2-week intervention study.
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Placebo comparator | Drug: Placebo oral capsule, Radiation: PET imagingplacebo oral capsule will be administered once daily, for 2 weeks |
| Treatment 2 | Experimental | Drug: Canagliflozin 100mg, Radiation: PET imagingCanagliflozine 100mg once daily, for 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HbA1c 7.5 -10.5%;
- LVEF < 40%;
- NYHA class 2 or 3;
- NT pro-BNP level > 600 pg/mL;
- Being on a stable-dose metformin therapy max 2500 mg/day or other hypoglycemic therapy and RAAS-blocking agents for at least 8 weeks;
Key exclusion criteria (17 listed)
- age <18 yo;
- NYHA class 4;
- Treatment with a fibrate or thiazolidinedione;
- Unstable or advanced renal failure;
- Unstable or new medical or surgical condition within the past 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canagliflozin 100mgAlso: Invokana2-week intervention | Drug | Treatment 2 |
| Placebo oral capsule2-week intervention | Drug | Treatment 1 |
| PET imaging1 day postprandial metabolic protocol at the end of treatment: CT scan followed by dynamic and pancorporel imaging | Radiation | Treatment 1, Treatment 2 |
Primary outcome
Change to be observed with canagliflozin on myocardial dietary fatty acid uptake
Time frame: 3 months
will be assessed using oral administration of 18-fluoro-thiaheptadecanoic acid ([18F]-FTHA) with sequential dynamic. PET/CT scanning.
Change to be observed with canagliflozin on whole-body partitioning.
Time frame: 3 months
will be assessed using oral administration of 18-fluoro-thiaheptadecanoic acid ([18F]-FTHA, with static PET/CT scanning
3 secondary outcomes
myocardial and liver NEFA uptake
Time frame: 3 months
NEFA oxidative rate
Time frame: 3 months
plasma NEFA turnover
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André C. Carpentier principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
A study testing Canagliflozin 100mg and PET imaging in people with Type2 Diabetes and Heart Failure, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change to be observed with canagliflozin on myocardial dietary fatty acid uptake (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.