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Early Identification of Heart Failure in a High-Risk Diabetic Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05866380
Recruitment Status : Recruiting
First Posted : May 19, 2023
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Chung-Lieh Hung, Mackay Memorial Hospital

Study Description
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Brief 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. Here, the investigators sought to investigate surrogate markers for predicting HF among type 2 diabetes patients of Asian ethnicities.

Condition or disease Intervention/treatment
Type2diabetes Other: heart failure risk factors

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
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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 23, 2022
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Intervention Details:
  • Other: heart failure risk factors
    observational study with diabetes patient with heart failure risk factors

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
T2DM patients, ethnic Asians, with established cardiovascular diseases or additional cardiovascular risk factors
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05866380


Contacts
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Contact: Chung-Lieh Hung, MD,PhD +886-975836018 jotaro3791@gmail.com
Contact: Jiun-Lu Lin, MD,MSc +886-975835896 jiunlulin@gmail.com

Locations
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Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Contact: Chung-Lieh Hung, MD,PD    +886975836018    jotaro3791@gmail.com   
Contact: Jiun-Lu Lin, MD,MSc    +886975835896    jiunlulin@gmail.com   
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
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Principal Investigator: Chung-Lieh Hung, MD.PhD MackayMemorial Hospital
More Information
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Responsible Party: Chung-Lieh Hung, Doctor, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT05866380    
Other Study ID Numbers: 20MMHIS365e
First Posted: May 19, 2023    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chung-Lieh Hung, Mackay Memorial Hospital:
Type2diabetes
Heart failure
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases