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

NCT05866380 | Active Not Recruiting

• 1 other identifier: 20MMHIS365e
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2diabetes

Keywords

Type2diabetes; Heart failure

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of recruitment until the date of first documented progression, with the minimum of 12 months of follow-up.

Interventions

heart failure risk factors OTHER

observational study with diabetes patient with heart failure risk factors

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

T2DM patients, ethnic Asians, with established cardiovascular diseases or additional cardiovascular risk factors

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Chung-Lieh Hung, MD.PhD

  MackayMemorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 19, 2023
• Study Start: March 23, 2022
• Primary Completion: March 1, 2025
• Study Completion: May 31, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)