Cardiovascular Risk FactorPhase 2DAPA-SWEETNCT04258371
DAPAgliflozin Sodium Water glucosE EffecTs in Patients at High Cardiovascular Risk
A Phase 2 study testing Dapagliflozin 10 MG in people with Cardiovascular Risk Factor, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study aims to elucidate the impact of SGLT2 inhibition on peripheral vascular function, renal function, fluid volume, neurohormonal activation and inflammatory/fibrotic pathways in patients with T2D at high cardiovascular risk and non-T2D patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Dapagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2020to Dec 2023
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eGFR ≥30 ml/min/1.73m2
- In patients with type 2 diabetes, HbA1c <12.0%
- Body Mass Index (BMI) 18.5-45.0 kg/m2
- Blood pressure < or = 160/100 at screening (sitting)
- Stable dose of maximally tolerated ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 30 days
- Stable diuretic dose for at least 14 days prior to baseline study Visit
- High cardiovascular risk: an age of 50 years or more with at least one cardiovascular coexisting condition (coronary heart disease, cerebrovascular disease, peripheral vascular disease, chronic kidney disease of stage 3 or greater, or chronic heart failure of New York Heart Association class II or III) OR an age of 60 years or more with at least one cardiovascular risk factor, as determined by the investigator (microalbuminuria or proteinuria, hypertension and left ventricular hypertrophy, left ventricular systolic or diastolic dysfunction, or an ankle-brachial index [the ratio of the systolic blood pressure at the ankle to the systolic blood pressure in the arm] of less than 0.9).
Who cannot join
- Type 1 Diabetes
- Iodine intolerance
- Hypersensitivity or allergy to dapagliflozin
- Use of an SGLT2 inhibitor within 30 days
- Leukocyte and/or nitrite positive urinalysis that is untreated
- Severe hypoglycaemia within 1 month prior to screening
Show all 20Show fewer
- Unstable coronary artery disease with acute coronary syndrome, percutaneous intervention or bypass surgery within 3 months
- Clinically significant valvular disease in the opinion of the investigator
- Congestive heart failure secondary to an infiltrative cardiomyopathic process (for example amyloid) or pericardial constriction
- Bariatric surgery or other surgeries that induce chronic malabsorption within 1 year;
- Anti-obesity drugs or diet regimen and unstable body weight three months prior to screening;
- Treatment with systemic corticosteroids
- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
- Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control
- Participation in another trial with an investigational drug within 30 days of informed consent
- Alcohol or drug abuse within three months prior to informed consent that would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement
- Liver disease, defined by serum levels of alanine transaminase, aspartate transaminase, or alkaline phosphatase >3 x upper limit of normal as determined during screening
- Medical history of cancer or treatment for cancer in the last five years prior to screening, aside from uncomplicated basal cell or squamous cell carcinoma;
- Unstable or rapidly progressive renal disease as per investigator judgement
- Intolerance or sensitivity to SGLT2 inhibitors
Trial locations and contacts
1 site in 1 country.
Yuliya Lytvyn, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Renal Physiology Laboratory
Toronto
Vesta Lai, RN, 416-340-4800 ext. 8508, vesta.lai@uhn.ca
Yuliya Lytvyn, PhD, julia.lytvyn@mail.utoronto.ca
About this study
This study aims to elucidate the impact of SGLT2 inhibition on peripheral vascular function, renal function, fluid volume, neurohormonal activation and inflammatory/fibrotic pathways in patients with T2D at high cardiovascular risk and non-T2D patients.
Read the detailed description
In light of EMPA-REG OUTCOME, CANVAS Program and DECLARE trials, we aim to elucidate the impact of SGLT2 inhibition on peripheral vascular function while also exploring the effects of this therapy on renal function, fluid volume, neurohormonal activation and inflammatory/fibrotic pathways in patients with T2D at high cardiovascular risk to best replicate the patient populations in recent cardiovascular outcome trials (CVOT), who are also participating in ongoing CVOTs such as VERTIS (ertugliflozin), as well as non-T2D patients in other ongoing trials examining cardiorenal effects of these therapies. We will test the hypothesis that in a high- risk population, regardless of T2D status, SGLT2 inhibition will improve markers of arterial stiffness (decreases in pulse wave velocity and augmentation index) in the study cohort - a surrogate marker of cardiovascular risk independent of glucose lowering. In addition, dapagliflozin will improve endothelial function ("flow-mediated vasodilatation" - FMD) and increase natriuresis (fractional excretion of sodium or FENa+), thereby reducing blood pressure, without inducing renal vasoconstriction or activation of the sympathetic nervous system (SNS). Based on extensive experimental literature, we also hypothesize that SGLT2 inhibition will suppress levels of pro-inflammatory/fibrotic mediators (see below) that have been linked with progression of cardiovascular and renal disease. The systematic understanding of the effects of SGLT2 inhibitors in the setting of patients at high cardiovascular risk will enable the design of rational physiology-based strategies to decrease the burden of cardiorenal disease, which could have important clinical and research implications. Data from DAPA-SWEET will also be valuable to better understand the results of trials that include patients using SGLT2 inhibitors as primary prevention strategies, such as in DECLARE TIMI-58.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Dapagliflozin 10 MG, Placebo oral tablet
- Keywords
- SGLT2 inhibition, Cardiovascular risk, Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MGDrug
Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks
Placebo oral tabletDrug
Placebo once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin Treatment Arm | Experimental | Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks Receives: Drug: Dapagliflozin 10 MG |
| Placebo Arm | Placebo comparator | Placebo Matching Dapagliflozin Tablet for 12 weeks Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Measured using a Sphygmocor device
Measured: Acute (1 week)
Arterial stiffness
Measured using a Sphygmocor device
Measured: Chronic (12 weeks)
Secondary outcomes (28)
Glomerular filtration rate
GFR
Measured: Glomerular Filtration Rate (GFR, based on plasma iohexol clearance) will be measured at 2 time points: acute (1 week) and chronic (12 weeks)
Flow mediated dilation
FMD
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Nitroglycerin mediated dilation
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Systolic blood pressure
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Diastolic blood pressure
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Heart rate
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Echocardiography
Changes to systolic and diastolic function
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Non-Invasive Cardiac Output Monitoring (Measured using a NICOM device)
Cardiac output and systemic vascular resistance
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Bioimpedence spectroscopy
Measure of extracellular water
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Plasma concentration of natriuretic peptides
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Plasma concentration of the renin-angiotensin aldosterone system (RAAS) hormones
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Nitric oxide
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Fractional excretion of sodium, using lithium clearance as a surrogate for proximal tubular sodium handling
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Urinary concentration of the renin-angiotensin aldosterone system (RAAS) markers
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Urinary adenosine
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of monocyte chemoattractant protein-1(MCP-1)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of intercellular adhesion molecule-1(ICAM-1)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of plasminogen activator inhibitor-1(PAI-1)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of transforming growth factor-beta (TGF-beta)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of connective tissue growth factor (CTGF)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of interleukins (IL-1beta, IL-6)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of tumour necrosis factor-alpha (TNF-alpha)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of matrix metalloproteinases 2 (MMP2)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of matrix metalloproteinases 9 (MMP9)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of advances glycation end-product (AGE)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of receptor for AGE (RAGE)
Measured in urine and skin biopsy samples
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Urinary thiobarbituric acid reactive substances (TBARS)
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Urinary 8-hydroxydeoxyguanosine (8-OHdG)
Measured: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start10 Feb 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to 10mg PO dapagliflozin daily or matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, MOUNT SINAI HOSPITAL
- Responsible party
- Principal investigator, David Z.I. Cherney, University Health Network, Toronto
- Investigators
- David ZI Cherney, MD PhD FRCPC, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258371
- Sponsor's protocol ID
- 18-5597
- Acronym
- DAPA-SWEET
- Status last verified
- May 2023
- First submitted
- 23 Jan 2020
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sridhar VS, Kugathasan L, Lytvyn Y, Deng Y, Liu H, Lovblom LE, Tse J, Nardone M, Floras JS, Osuntokun T, Tobushi T, Lam RCY, Lam B, Stevens J, Burger D, Touw DJ, Heerspink HJL, Lovshin JA, Perkins BA, Cherney DZI. Cardiovascular-Kidney Effects of Dapagliflozin in Patients at Cardiovascular Risk With or Without Type 2 Diabetes: Results of a Randomized, Double-Blind, Placebo-Controlled Trial. Hypertension. 2026 Feb;83(2):e25955. doi: 10.1161/HYPERTENSIONAHA.125.25955. Epub 2025 Dec 5.
PubMed 41347301
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAPAgliflozin Sodium Water glucosE EffecTs in Patients at High Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT04258371
- Acronym / sponsor ID
- DAPA-SWEET / 18-5597
- Conditions
- Cardiovascular Risk Factor
- Keywords
- SGLT2 inhibition, Cardiovascular risk, Dapagliflozin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, MOUNT SINAI HOSPITAL
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Feb 2020 (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.
This study aims to elucidate the impact of SGLT2 inhibition on peripheral vascular function, renal function, fluid volume, neurohormonal activation and inflammatory/fibrotic pathways in patients with T2D at high cardiovascular risk and non-T2D patients.
Detailed description
In light of EMPA-REG OUTCOME, CANVAS Program and DECLARE trials, we aim to elucidate the impact of SGLT2 inhibition on peripheral vascular function while also exploring the effects of this therapy on renal function, fluid volume, neurohormonal activation and inflammatory/fibrotic pathways in patients with T2D at high cardiovascular risk to best replicate the patient populations in recent cardiovascular outcome trials (CVOT), who are also participating in ongoing CVOTs such as VERTIS (ertugliflozin), as well as non-T2D patients in other ongoing trials examining cardiorenal effects of these therapies. We will test the hypothesis that in a high- risk population, regardless of T2D status, SGLT2 inhibition will improve markers of arterial stiffness (decreases in pulse wave velocity and augmentation index) in the study cohort - a surrogate marker of cardiovascular risk independent of glucose lowering. In addition, dapagliflozin will improve endothelial function ("flow-mediated vasodilatation" - FMD) and increase natriuresis (fractional excretion of sodium or FENa+), thereby reducing blood pressure, without inducing renal vasoconstriction or activation of the sympathetic nervous system (SNS). Based on extensive experimental literature, we also hypothesize that SGLT2 inhibition will suppress levels of pro-inflammatory/fibrotic mediators (see below) that have been linked with progression of cardiovascular and renal disease. The systematic understanding of the effects of SGLT2 inhibitors in the setting of patients at high cardiovascular risk will enable the design of rational physiology-based strategies to decrease the burden of cardiorenal disease, which could have important clinical and research implications. Data from DAPA-SWEET will also be valuable to better understand the results of trials that include patients using SGLT2 inhibitors as primary prevention strategies, such as in DECLARE TIMI-58.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to 10mg PO dapagliflozin daily or matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin Treatment Arm | Experimental | Drug: Dapagliflozin 10 MGDapagliflozin Tablets Total Dose 10mg daily for 12 weeks |
| Placebo Arm | Placebo comparator | Drug: Placebo oral tabletPlacebo Matching Dapagliflozin Tablet for 12 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- eGFR ≥30 ml/min/1.73m2
- In patients with type 2 diabetes, HbA1c <12.0%
- Body Mass Index (BMI) 18.5-45.0 kg/m2
- Blood pressure < or = 160/100 at screening (sitting)
- Stable dose of maximally tolerated ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 30 days
Key exclusion criteria (20 listed)
- Type 1 Diabetes
- Iodine intolerance
- Hypersensitivity or allergy to dapagliflozin
- Use of an SGLT2 inhibitor within 30 days
- Leukocyte and/or nitrite positive urinalysis that is untreated
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 |
|---|---|---|
| Dapagliflozin 10 MGDapagliflozin Tablets Total Dose 10mg daily for 12 weeks | Drug | Dapagliflozin Treatment Arm |
| Placebo oral tabletPlacebo once daily for 12 weeks | Drug | Placebo Arm |
Primary outcome
Arterial stiffness
Time frame: Acute (1 week)
Measured using a Sphygmocor device
Arterial stiffness
Time frame: Chronic (12 weeks)
Measured using a Sphygmocor device
28 secondary outcomes
Glomerular filtration rate
Time frame: Glomerular Filtration Rate (GFR, based on plasma iohexol clearance) will be measured at 2 time points: acute (1 week) and chronic (12 weeks)
Flow mediated dilation
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Nitroglycerin mediated dilation
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Systolic blood pressure
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Diastolic blood pressure
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Heart rate
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Echocardiography
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Non-Invasive Cardiac Output Monitoring (Measured using a NICOM device)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Bioimpedence spectroscopy
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Plasma concentration of natriuretic peptides
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Plasma concentration of the renin-angiotensin aldosterone system (RAAS) hormones
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Nitric oxide
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Fractional excretion of sodium, using lithium clearance as a surrogate for proximal tubular sodium handling
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Urinary concentration of the renin-angiotensin aldosterone system (RAAS) markers
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Urinary adenosine
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of monocyte chemoattractant protein-1(MCP-1)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of intercellular adhesion molecule-1(ICAM-1)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of plasminogen activator inhibitor-1(PAI-1)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of transforming growth factor-beta (TGF-beta)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of connective tissue growth factor (CTGF)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of interleukins (IL-1beta, IL-6)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of tumour necrosis factor-alpha (TNF-alpha)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of matrix metalloproteinases 2 (MMP2)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of matrix metalloproteinases 9 (MMP9)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of advances glycation end-product (AGE)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
mRNA expression of receptor for AGE (RAGE)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Urinary thiobarbituric acid reactive substances (TBARS)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Urinary 8-hydroxydeoxyguanosine (8-OHdG)
Time frame: Outcome will remeasured at 2 time points: acute (1 week) and chronic (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 41347301Sridhar VS, Kugathasan L, Lytvyn Y, Deng Y, Liu H, Lovblom LE, Tse J, Nardone M, Floras JS, Osuntokun T, Tobushi T, Lam RCY, Lam B, Stevens J, Burger D, Touw DJ, Heerspink HJL, Lovshin JA, Perkins BA, Cherney DZI. Cardiovascular-Kidney Effects of Dapagliflozin in Patients at Cardiovascular Risk With or Without Type 2 Diabetes: Results of a Randomized, Double-Blind, Placebo-Controlled Trial. Hypertension. 2026 Feb;83(2):e25955. doi: 10.1161/HYPERTENSIONAHA.125.25955. Epub 2025 Dec 5.
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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.
Yuliya Lytvyn, PhD contact
David ZI Cherney, MD PhD FRCPC principal investigator
University Health Network, Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10 MG in people with Cardiovascular Risk Factor, run by University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vesta Lai, RN (416-340-4800 ext. 8508, vesta.lai@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: Acute (1 week)). 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?
On the ClinicalTrials.gov record for NCT04258371, which also lists 1 linked publication.
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 17 May 2023.