DiabetesPhase 4EMPA-HEARTNCT02998970
Effects of Empagliflozin on Cardiac Structure in Patients With Type 2 Diabetes
A Phase 4 study testing Empagliflozin in people with Diabetes and Cardiovascular Disease, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure, function and circulating biomarkers in patients with Type II diabetes. Empagliflozin (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type II diabetes, demonstrated a reduction in… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes, Cardiovascular Disease
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Sep 2018
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ≥40 and ≤ 80 years of age
- History of type 2 diabetes
- Haemoglobin A1C ≥6.5 and ≤10 % within 3 months of the Screening Visit
- Established cardiovascular disease, defined as previous myocardial infarction ≥ 6 months ago, or previous coronary revascularization ≥ 2 months ago
- Any background antihyperglycemic therapy (which has been stable for at least 2 months)
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
Who cannot join
- Female subjects who are pregnant, lactating or of child bearing potential, or pre-menopausal women. (Menopause will be determined by patient and physician history)
- Type 1 diabetes
- Subjects currently treated with SGLT2 inhibitors, Glucagon-like peptide-1 (GLP1) receptor agonist, or saxagliptin
- Frequent episodes (>4/month) of moderate hypoglycaemia, as defined by the Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes
- Any episode of severe hypoglycaemia within the past 12 months, as also defined by the Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes
- Subjects in whom coronary revascularisation by either Percutaneous coronary intervention (PCI) or bypass surgery is being contemplated within 6 months, or who have undergone revascularisation in the prior 2 months
Show all 20Show fewer
- Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR)< 60 ml/min/1.73 m2 at screening
- Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations
- Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, haematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease and psychiatric disease
- Any malignancy not considered cured (except basal cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
- Blood donation within 4 weeks prior to screening, or stated intention to donate blood or blood products during the period of the study or within one month following completion of the study
- Subjects who have participated in studies of an investigational drug or device within 30 days prior to the screening visit
- Conditions preventing safe MRI imaging such as the subject's weight exceeding 500 lbs; maximum body dimension from side-to-side exceeding 70 cm and from back to front of torso exceeding 50 cm or the presence of metallic fragments, clips or devices
- LVEF <30% on the most recent assessment within 6 months
- New York Heart Association (NYHA) Class IV or recent hospitalization for decompensated Heart Failure (HF) (<3 months)
- Unstable coronary syndromes
- Moderate or severe aortic stenosis
- Moderate or severe aortic regurgitation
- Moderate or severe mitral stenosis
- Moderate or severe mitral regurgitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Empagliflozin on Cardiac Structure, Function, and Circulating Biomarkers in Patients With Type 2 Diabetes
The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure, function and circulating biomarkers in patients with Type II diabetes. Empagliflozin (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a previous post-marketing clinical trial. The use of empagliflozin to treat patients with diabetes and heart disease has been approved by Health Canada. However, the process by which it may give this beneficial effect remains unclear and needs further investigation. Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic basis by which Empagliflozin could provide its potential cardio-protective effects by employing the use of Cardiac Magnetic Resonance Imaging (CMRI).
Read the detailed description
The prevalence of heart failure in Canada is high, affecting 1-3% of total population, representing one of the health care system's most expensive diagnoses. Type 2 diabetes is a significant risk factor for heart disease, and the presence of both type 2 diabetes and heart disease increases the risk of other major health complications including death. A translational study is fundamental in understanding of the potential mechanistic basis of empagliflozin's cardiac benefit.
The study drug, empagliflozin (marketed as Jardiance), belongs to a class of medications that lowers blood glucose (sugar) by preventing glucose from entering back into blood circulation and ensures it is eliminated in urine. It is approved by the FDA and Health Canada for the treatment of type 2 diabetes.
This is a double-blind, randomized, placebo-controlled, parallel-group phase IV study of empagliflozin vs. placebo in patients with type 2 diabetes with inadequate glycemic control and at high cardiovascular risk. The purpose is to better understand how empagliflozin could potentially improve heart function with the use of CMRI. Patients who have given informed consent will undergo a baseline CMRI and will then be randomly assigned in a 1:1 basis to either empagliflozin 10 mg once daily (OD) or matching placebo. The aim of the study is to consent 90 eligible subjects, who will be followed for 26 weeks. An end of study CMRI will be performed at 26 weeks.
The study is comprised of 6 study visits and enrolled subjects will be followed for 6 months. The patients will be assessed using CMRI, which is considered the "gold standard" for measuring left ventricular (LV) volume, mass, and ejection fraction. Patients will undergo two CMRI examinations: at baseline and 6 months after surgery.
In addition, the investigators will be investigating changes from baseline in LV end-diastolic volume, end-systolic volume, LV ejection fraction, regional LV diastolic and systolic function, aortic pulse wave velocity and distensibility (as measures of arterial stiffness) via CMR imaging in patients with type 2 diabetes treated with empagliflozin compared to those who receive placebo. Also, changes from baseline on a panel of biomarkers involved in the pathophysiology of heart will be evaluated at baseline, 1 months and 6 months, in patients with type 2 diabetes treated with empagliflozin.
Study assessments and potential adverse events reporting will be undertaken at each study visit.
- Conditions
- Diabetes, Cardiovascular Disease
- Being tested
- Empagliflozin, Placebo
- Keywords
- Cardiovascular Disease, Type 2 Diabetes, Cardiac Magnetic Resonance Imaging
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
single oral tablet once daily.
PlaceboDrug
single oral tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo group acts as a control group. This is in order to objectively isolate empagliflozin's effect on cardiac structure and function as determined by CMR imaging. Receives: Drug: Placebo |
| Empagliflozin | Active comparator | The study medication (Jardiance) is the only diabetes medication to show a significant reduction in both cardiovascular risk and cardiovascular death. The generic name is empagliflozin and will be provided by Boehringer-Ingelheim. If the patient is randomized into the study drug group patients will receive empagliflozin 10 mg tablets once daily for a duration of 6 months. Receives: Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular (LV) mass Changes
Changes in Left Ventricular (LV) mass (indexed to BSA) at 6 months in patients with Type 2 diabetes who receive empagliflozin vs. placebo.
This will be measured using CMRI.
Measured: 6 months
Secondary outcomes (8)
LV end-diastolic volume
Changes in LV end-diastolic volume (indexed to BSA) at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin.
This will be measured using CMRI.
Measured: 6 months
End-systolic volume (indexed to BSA)
Changes in end-systolic volume (indexed to BSA) at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin.
This will be measured using CMRI.
Measured: 6 months
Left Ventricular Ejection Fraction (LVEF)
Changes LVEF at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin.
This will be measured using CMRI.
Measured: 6 months
Regional LV diastolic function
Changes in Regional LV diastolic function at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin.
This will be measured using CMRI.
Measured: 6 months
Regional LV systolic function
Changes in Regional LV systolic function at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin.
This will be measured using CMRI.
Measured: 6 months
Aortic pulse wave velocity and distensibility
Changes in aortic pulse wave velocity and distensibility (as arterial stiffness) at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin.
Measured: 6 months
Biomarkers
Changes on a panel of biomarkers involved in the pathophysiology of heart failure at baseline, 1 months and 6 months, in patients with type 2 diabetes treated with empagliflozin.
Measured: 6 months
Plasma catecholamine levels
Changes in plasma catecholamine levels at baseline, 1 months and 6 months, in patients with type 2 diabetes treated with empagliflozin.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Unity Health 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998970
- Sponsor's protocol ID
- REB# 15-402
- Acronym
- EMPA-HEART
- Status last verified
- Aug 2018
- First submitted
- 5 Dec 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pourafkari M, Connelly KA, Verma S, Mazer CD, Teoh H, Quan A, Goodman SG, Rai A, Ng MY, Deva DP, Triverio P, Jiminez-Juan L, Yan AT, Ge Y. Empagliflozin and left atrial function in patients with type 2 diabetes mellitus and coronary artery disease: insight from the EMPA-HEART CardioLink-6 randomized clinical trial. Cardiovasc Diabetol. 2024 Aug 28;23(1):319. doi: 10.1186/s12933-024-02344-6.
PubMed 39198860Barbour W, Wolff E, Puar P, Hibino M, Bakbak E, Krishnaraj A, Verma R, Verma M, Quan A, Yan AT, Connelly KA, Teoh H, Mazer CD, Verma S. Effect of empagliflozin on cardiac remodelling in South Asian and non-South Asian individuals: insights from the EMPA-HEART CardioLink-6 randomised clinical trial. BMC Cardiovasc Disord. 2023 Nov 15;23(1):557. doi: 10.1186/s12872-023-03549-5.
PubMed 37964221Puar P, Ahmed S, Hibino M, Pasricha A, Pandey A, Bari A, Verma R, Quan A, Yan AT, Connelly KA, Teoh H, Mazer CD, Verma S. The association between anthropometric indicators of obesity and cardiac reverse remodelling with empagliflozin in patients with type 2 diabetes and coronary artery disease. Diabetes Obes Metab. 2023 Sep;25(9):2765-2769. doi: 10.1111/dom.15119. Epub 2023 May 29. No abstract available.
PubMed 37246798Sarak B, Verma S, David Mazer C, Teoh H, Quan A, Gilbert RE, Goodman SG, Bami K, Coelho-Filho OR, Ahooja V, Deva DP, Garg V, Gandhi S, Connelly KA, Yan AT. Impact of empagliflozin on right ventricular parameters and function among patients with type 2 diabetes. Cardiovasc Diabetol. 2021 Oct 4;20(1):200. doi: 10.1186/s12933-021-01390-8.
PubMed 34607574Mason T, Coelho-Filho OR, Verma S, Chowdhury B, Zuo F, Quan A, Thorpe KE, Bonneau C, Teoh H, Gilbert RE, Leiter LA, Juni P, Zinman B, Jerosch-Herold M, Mazer CD, Yan AT, Connelly KA. Empagliflozin Reduces Myocardial Extracellular Volume in Patients With Type 2 Diabetes and Coronary Artery Disease. JACC Cardiovasc Imaging. 2021 Jun;14(6):1164-1173. doi: 10.1016/j.jcmg.2020.10.017. Epub 2021 Jan 13.
PubMed 33454272Verma S, Mazer CD, Yan AT, Mason T, Garg V, Teoh H, Zuo F, Quan A, Farkouh ME, Fitchett DH, Goodman SG, Goldenberg RM, Al-Omran M, Gilbert RE, Bhatt DL, Leiter LA, Juni P, Zinman B, Connelly KA. Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial. Circulation. 2019 Nov 19;140(21):1693-1702. doi: 10.1161/CIRCULATIONAHA.119.042375. Epub 2019 Aug 22.
PubMed 31434508
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Empagliflozin on Cardiac Structure, Function, and Circulating Biomarkers in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02998970
- Acronym / sponsor ID
- EMPA-HEART / REB# 15-402
- Conditions
- Diabetes, Cardiovascular Disease
- Keywords
- Cardiovascular Disease, Type 2 Diabetes, Cardiac Magnetic Resonance Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- 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.
The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure, function and circulating biomarkers in patients with Type II diabetes. Empagliflozin (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a previous post-marketing clinical trial. The use of empagliflozin to treat patients with diabetes and heart disease has been approved by Health Canada. However, the process by which it may give this beneficial effect remains unclear and needs further investigation. Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic basis by which Empagliflozin could provide its potential cardio-protective effects by employing the use of Cardiac Magnetic Resonance Imaging (CMRI).
Detailed description
The prevalence of heart failure in Canada is high, affecting 1-3% of total population, representing one of the health care system's most expensive diagnoses. Type 2 diabetes is a significant risk factor for heart disease, and the presence of both type 2 diabetes and heart disease increases the risk of other major health complications including death. A translational study is fundamental in understanding of the potential mechanistic basis of empagliflozin's cardiac benefit.
The study drug, empagliflozin (marketed as Jardiance), belongs to a class of medications that lowers blood glucose (sugar) by preventing glucose from entering back into blood circulation and ensures it is eliminated in urine. It is approved by the FDA and Health Canada for the treatment of type 2 diabetes.
This is a double-blind, randomized, placebo-controlled, parallel-group phase IV study of empagliflozin vs. placebo in patients with type 2 diabetes with inadequate glycemic control and at high cardiovascular risk. The purpose is to better understand how empagliflozin could potentially improve heart function with the use of CMRI. Patients who have given informed consent will undergo a baseline CMRI and will then be randomly assigned in a 1:1 basis to either empagliflozin 10 mg once daily (OD) or matching placebo. The aim of the study is to consent 90 eligible subjects, who will be followed for 26 weeks. An end of study CMRI will be performed at 26 weeks.
The study is comprised of 6 study visits and enrolled subjects will be followed for 6 months. The patients will be assessed using CMRI, which is considered the "gold standard" for measuring left ventricular (LV) volume, mass, and ejection fraction. Patients will undergo two CMRI examinations: at baseline and 6 months after surgery.
In addition, the investigators will be investigating changes from baseline in LV end-diastolic volume, end-systolic volume, LV ejection fraction, regional LV diastolic and systolic function, aortic pulse wave velocity and distensibility (as measures of arterial stiffness) via CMR imaging in patients with type 2 diabetes treated with empagliflozin compared to those who receive placebo. Also, changes from baseline on a panel of biomarkers involved in the pathophysiology of heart will be evaluated at baseline, 1 months and 6 months, in patients with type 2 diabetes treated with empagliflozin.
Study assessments and potential adverse events reporting will be undertaken at each study visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe placebo group acts as a control group. This is in order to objectively isolate empagliflozin's effect on cardiac structure and function as determined by CMR imaging. |
| Empagliflozin | Active comparator | Drug: EmpagliflozinThe study medication (Jardiance) is the only diabetes medication to show a significant reduction in both cardiovascular risk and cardiovascular death. The generic name is empagliflozin and will be provided by Boehringer-Ingelheim. If the patient is randomized into the study drug group patients will receive empagliflozin 10 mg tablets once daily for a duration of 6 months. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects ≥40 and ≤ 80 years of age
- History of type 2 diabetes
- Haemoglobin A1C ≥6.5 and ≤10 % within 3 months of the Screening Visit
- Established cardiovascular disease, defined as previous myocardial infarction ≥ 6 months ago, or previous coronary revascularization ≥ 2 months ago
- Any background antihyperglycemic therapy (which has been stable for at least 2 months)
Key exclusion criteria (20 listed)
- Female subjects who are pregnant, lactating or of child bearing potential, or pre-menopausal women. (Menopause will be determined by patient and physician history)
- Type 1 diabetes
- Subjects currently treated with SGLT2 inhibitors, Glucagon-like peptide-1 (GLP1) receptor agonist, or saxagliptin
- Frequent episodes (>4/month) of moderate hypoglycaemia, as defined by the Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes
- Any episode of severe hypoglycaemia within the past 12 months, as also defined by the Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes
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 |
|---|---|---|
| EmpagliflozinAlso: Jardiancesingle oral tablet once daily. | Drug | Empagliflozin |
| Placebosingle oral tablet once daily. | Drug | Placebo |
Primary outcome
Left Ventricular (LV) mass Changes
Time frame: 6 months
Changes in Left Ventricular (LV) mass (indexed to BSA) at 6 months in patients with Type 2 diabetes who receive empagliflozin vs. placebo. This will be measured using CMRI.
8 secondary outcomes
LV end-diastolic volume
Time frame: 6 months
End-systolic volume (indexed to BSA)
Time frame: 6 months
Left Ventricular Ejection Fraction (LVEF)
Time frame: 6 months
Regional LV diastolic function
Time frame: 6 months
Regional LV systolic function
Time frame: 6 months
Aortic pulse wave velocity and distensibility
Time frame: 6 months
Biomarkers
Time frame: 6 months
Plasma catecholamine levels
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 39198860Pourafkari M, Connelly KA, Verma S, Mazer CD, Teoh H, Quan A, Goodman SG, Rai A, Ng MY, Deva DP, Triverio P, Jiminez-Juan L, Yan AT, Ge Y. Empagliflozin and left atrial function in patients with type 2 diabetes mellitus and coronary artery disease: insight from the EMPA-HEART CardioLink-6 randomized clinical trial. Cardiovasc Diabetol. 2024 Aug 28;23(1):319. doi: 10.1186/s12933-024-02344-6.
- Derived from this study: PubMed 37964221Barbour W, Wolff E, Puar P, Hibino M, Bakbak E, Krishnaraj A, Verma R, Verma M, Quan A, Yan AT, Connelly KA, Teoh H, Mazer CD, Verma S. Effect of empagliflozin on cardiac remodelling in South Asian and non-South Asian individuals: insights from the EMPA-HEART CardioLink-6 randomised clinical trial. BMC Cardiovasc Disord. 2023 Nov 15;23(1):557. doi: 10.1186/s12872-023-03549-5.
- Derived from this study: PubMed 37246798Puar P, Ahmed S, Hibino M, Pasricha A, Pandey A, Bari A, Verma R, Quan A, Yan AT, Connelly KA, Teoh H, Mazer CD, Verma S. The association between anthropometric indicators of obesity and cardiac reverse remodelling with empagliflozin in patients with type 2 diabetes and coronary artery disease. Diabetes Obes Metab. 2023 Sep;25(9):2765-2769. doi: 10.1111/dom.15119. Epub 2023 May 29. No abstract available.
- Derived from this study: PubMed 34607574Sarak B, Verma S, David Mazer C, Teoh H, Quan A, Gilbert RE, Goodman SG, Bami K, Coelho-Filho OR, Ahooja V, Deva DP, Garg V, Gandhi S, Connelly KA, Yan AT. Impact of empagliflozin on right ventricular parameters and function among patients with type 2 diabetes. Cardiovasc Diabetol. 2021 Oct 4;20(1):200. doi: 10.1186/s12933-021-01390-8.
- Derived from this study: PubMed 33454272Mason T, Coelho-Filho OR, Verma S, Chowdhury B, Zuo F, Quan A, Thorpe KE, Bonneau C, Teoh H, Gilbert RE, Leiter LA, Juni P, Zinman B, Jerosch-Herold M, Mazer CD, Yan AT, Connelly KA. Empagliflozin Reduces Myocardial Extracellular Volume in Patients With Type 2 Diabetes and Coronary Artery Disease. JACC Cardiovasc Imaging. 2021 Jun;14(6):1164-1173. doi: 10.1016/j.jcmg.2020.10.017. Epub 2021 Jan 13.
- Derived from this study: PubMed 31434508Verma S, Mazer CD, Yan AT, Mason T, Garg V, Teoh H, Zuo F, Quan A, Farkouh ME, Fitchett DH, Goodman SG, Goldenberg RM, Al-Omran M, Gilbert RE, Bhatt DL, Leiter LA, Juni P, Zinman B, Connelly KA. Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial. Circulation. 2019 Nov 19;140(21):1693-1702. doi: 10.1161/CIRCULATIONAHA.119.042375. Epub 2019 Aug 22.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin in people with Diabetes and Cardiovascular Disease, run by Unity Health 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 15 Aug 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Left Ventricular (LV) mass Changes (time frame: 6 months). 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 NCT02998970, which also lists 6 linked publications.
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 15 Aug 2018.