Type2diabetesNCT05866380
Early Identification of Heart Failure in a High-Risk Diabetic Cohort
An observational study of Type2diabetes, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Type 2 diabetes is an important co-morbid condition strongly associated with the risk of developing heart failure (HF). Risk scores such as the WATCH-DM score that predict the occurrence of HF among diabetes patients are largely based on data collected from white ethnicities. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- heart failure risk factors
- How many people
- 3,500 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Mar 2022to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: T2DM patients, ethnic Asians, with established cardiovascular diseases or additional cardiovascular risk factors
Who may be able to join
- Type 2 diabetes T2DM for at least six months;
- ≥ 20 years of age, men or women;
- Patients who had either established cardiovascular disease or additional cardiovascular risk factors;
- Free at baseline of diagnosed HF, while patients might be stage A-B HF based on ACC/AHA Heart Failure Classification, with baseline clinical information and NTproBNP data available;
- Baseline patient-level clinical data available.
Who cannot join
- eGFR <30ml/min/1.73m2;
- Known HF hospitalization history;
- Known impaired LV systolic function (LVEF<40%) by any imaging modality;
- Any terminal disease other than diabetes lowering the patient's life expectancy to less than two years;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Identification of Heart Failure in Diabetes With Known Cardiovascular Risk or Established Cardiovascular Disease in A Large-scale Asian Diabetic Population: A Multi-center Cohort Study
Type 2 diabetes is an important co-morbid condition strongly associated with the risk of developing heart failure (HF). Risk scores such as the WATCH-DM score that predict the occurrence of HF among diabetes patients are largely based on data collected from white ethnicities. Here, the investigators sought to investigate surrogate markers for predicting HF among type 2 diabetes patients of Asian ethnicities.
Read the detailed description
Patients with type 2 diabetes (T2D) suffer from diverse complications, including atherosclerotic cardiovascular disease (ASCVD), diabetic cardiomyopathy and heart failure (HF), which accounts for a substantial burden of death and disability worldwide. Epidemiological studies have pointed out the projected global diabetes trends with estimated 642 million by 2040. On the other hand, patients with HF are accompanied by high burden of T2D, which in turn exacerbate grave prognosis of HF. Despite the observed benefits in controlling risk factors of hypertension, ...etc. in preventing incident HF, efforts has lead to little effect from strict sugar control in diabetic patients.
Recent cardiovascular outcomes trials (CVOTs) have shown substantial improvement on cardiovascular protective effects and end-points with novel SGLT2 inhibitors, particularly in HF, yet data regarding the exact clinical characteristics and risk stratification in diabetes subjects that interventions may help remained largely unexplored. To date, several baseline clinical information along with biomarker N-terminal pro-brain natriuretic peptide (NT-proBNP) have shown to be predictors of HF. According to WATCH-DM sub-study based on The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, a variety of clinical variables, including age, gender, body size, blood pressure, dys-glycemic indices and lipid profiles haven shown to identify the clinical risks for HF in T2D patients. Beyond clinical risk factors, biomarkers of NT-proBNP, a sensitive serum marker for cardiac damage and pre-clinical myocardial dysfunction, has also shown novelty in identifying diabetic subjects with subclinical cardiac dysfunction or with higher HF risk starting from relatively lower clinical cut-offs (NTproBNP≧50 pg/mL) that may benefit from SGLT2i treatment.
This trial is a multi-center clinical study in Mackay Memorial Hospital, National Taiwan University Hospital and Far Eastern Memorial Hospital. A total 5000 adult T2D patients will be prospectively enrolled from outpatient clinics (1500-3500 patients each center). 5000 - 10000 retrospective medical record reviews (3000 - 7000 each center) for baseline characteristics and general biochemical examination results collection ( including blood sugar, glycated hemoglobin, lipid profile, liver function, renal function and microalbuminuria), EKG. WATCH-DM score collection and heart function related biomarkers test including NTproBNP will be arranged.
Through the value of biomarker detection, high-risk type 2 diabetes patients who have not previously caused heart disease can be identified, and the epidemiology of high-risk Asian type 2 diabetes with preclinical HF will be elucidated by large-scale cohort research.
- Conditions
- Type2diabetes
- Being tested
- heart failure risk factors
- Keywords
- Type2diabetes, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart failure risk factorsOther
observational study with diabetes patient with heart failure risk factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Major adverse cardiovascular events defined as a composite of hospitalization for heart failure, death from cardiovascular causes and nonfatal myocardial infarction.
Measured: From date of recruitment until the date of first documented progression, with the minimum of 12 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start23 Mar 2022
- Primary completion1 Mar 2025
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung-Lieh Hung, Mackay Memorial Hospital
- Investigators
- Chung-Lieh Hung, MD.PhD, Principal investigator, MackayMemorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866380
- Sponsor's protocol ID
- 20MMHIS365e
- Status last verified
- Apr 2025
- First submitted
- 8 May 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Heart Failure in Diabetes With Known Cardiovascular Risk or Established Cardiovascular Disease in A Large-scale Asian Diabetic Population: A Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT05866380
- Acronym / sponsor ID
- 20MMHIS365e
- Conditions
- Type2diabetes
- Keywords
- Type2diabetes, Heart failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 19 May 2023 (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.
Type 2 diabetes is an important co-morbid condition strongly associated with the risk of developing heart failure (HF). Risk scores such as the WATCH-DM score that predict the occurrence of HF among diabetes patients are largely based on data collected from white ethnicities. Here, the investigators sought to investigate surrogate markers for predicting HF among type 2 diabetes patients of Asian ethnicities.
Detailed description
Patients with type 2 diabetes (T2D) suffer from diverse complications, including atherosclerotic cardiovascular disease (ASCVD), diabetic cardiomyopathy and heart failure (HF), which accounts for a substantial burden of death and disability worldwide. Epidemiological studies have pointed out the projected global diabetes trends with estimated 642 million by 2040. On the other hand, patients with HF are accompanied by high burden of T2D, which in turn exacerbate grave prognosis of HF. Despite the observed benefits in controlling risk factors of hypertension, ...etc. in preventing incident HF, efforts has lead to little effect from strict sugar control in diabetic patients.
Recent cardiovascular outcomes trials (CVOTs) have shown substantial improvement on cardiovascular protective effects and end-points with novel SGLT2 inhibitors, particularly in HF, yet data regarding the exact clinical characteristics and risk stratification in diabetes subjects that interventions may help remained largely unexplored. To date, several baseline clinical information along with biomarker N-terminal pro-brain natriuretic peptide (NT-proBNP) have shown to be predictors of HF. According to WATCH-DM sub-study based on The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, a variety of clinical variables, including age, gender, body size, blood pressure, dys-glycemic indices and lipid profiles haven shown to identify the clinical risks for HF in T2D patients. Beyond clinical risk factors, biomarkers of NT-proBNP, a sensitive serum marker for cardiac damage and pre-clinical myocardial dysfunction, has also shown novelty in identifying diabetic subjects with subclinical cardiac dysfunction or with higher HF risk starting from relatively lower clinical cut-offs (NTproBNP≧50 pg/mL) that may benefit from SGLT2i treatment.
This trial is a multi-center clinical study in Mackay Memorial Hospital, National Taiwan University Hospital and Far Eastern Memorial Hospital. A total 5000 adult T2D patients will be prospectively enrolled from outpatient clinics (1500-3500 patients each center). 5000 - 10000 retrospective medical record reviews (3000 - 7000 each center) for baseline characteristics and general biochemical examination results collection ( including blood sugar, glycated hemoglobin, lipid profile, liver function, renal function and microalbuminuria), EKG. WATCH-DM score collection and heart function related biomarkers test including NTproBNP will be arranged.
Through the value of biomarker detection, high-risk type 2 diabetes patients who have not previously caused heart disease can be identified, and the epidemiology of high-risk Asian type 2 diabetes with preclinical HF will be elucidated by large-scale cohort research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- T2DM patients, ethnic Asians, with established cardiovascular diseases or additional cardiovascular risk factors
Key inclusion criteria (5 listed)
- Type 2 diabetes T2DM for at least six months;
- ≥ 20 years of age, men or women;
- Patients who had either established cardiovascular disease or additional cardiovascular risk factors;
- Free at baseline of diagnosed HF, while patients might be stage A-B HF based on ACC/AHA Heart Failure Classification, with baseline clinical information and NTproBNP data available;
- Baseline patient-level clinical data available.
Key exclusion criteria (5 listed)
- eGFR <30ml/min/1.73m2;
- Known HF hospitalization history;
- Known impaired LV systolic function (LVEF<40%) by any imaging modality;
- Any terminal disease other than diabetes lowering the patient's life expectancy to less than two years;
- Pregnant women.
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 |
|---|---|---|
| heart failure risk factorsobservational study with diabetes patient with heart failure risk factors | Other | – |
Primary outcome
Major adverse cardiovascular events
Time frame: From date of recruitment until the date of first documented progression, with the minimum of 12 months of follow-up.
Major adverse cardiovascular events defined as a composite of hospitalization for heart failure, death from cardiovascular causes and nonfatal myocardial infarction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- 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.
Chung-Lieh Hung, MD.PhD principal investigator
MackayMemorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2diabetes, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. 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 Taiwan. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Major adverse cardiovascular events (time frame: From date of recruitment until the date of first documented progression, with the minimum of 12 months of follow-up.). 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 15 Apr 2025.