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

May 17, 2023 updated by: Chung-Lieh Hung, Mackay Memorial Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of recruitment until the date of first documented progression, with the minimum of 12 months of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: Chung-Lieh Hung, MD.PhD, MackayMemorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20MMHIS365e

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type2diabetes

Clinical Trials on heart failure risk factors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe