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Completed

NCT Number: NCT05538819

The Effects of Glimepiride in Patients With Type 2 Diabetes and Chronic Heart Failure

Thirty years ago, Dzau and Braunwald introduced the concept of a continuum of cardiovascular diseases and defined them as a series of events caused by numerous related and unrelated risk factors, thus developing to end-stage heart disease through many pathophysiological pathways and processes. Owing to treatment concept changes and the urgency of investigating T2D combined with CHF, SUs are being re-evaluated, of which glimepiride is undoubtedly the most promising.

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Key information

Conditions

Chronic Heart Failure Cardiovascular Mortality Cohort Study Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

Since the first sulfonylurea (SU; tolbutamide) was commercially launched in Germany in 1956, SUs, as the oldest oral hypoglycemic drugs, have been developed for three generations and are commonly used for patients with T2D. In 2008, the US Food and Drug Administration and European Drug Administration required cardiovascular safety certification for all hypoglycemic drugs, resulting in increased related clinical trials. Currently, data on the relationship between SUs and cardiovascular outcomes are limited, and the cardiovascular effects remain controversial in observational studies. Third-generation SUs, such as glimepiride, are widely used for treating T2D because of their definite hypoglycemic efficacy, relatively low risk of hypoglycemia, convenient daily use, and low price. Glimepiride has good cardiovascular safety according to randomized controlled trials (RCTs). The proportion of SUs used in patients with heart failure is as high as 60.4%. Although some studies have shown that SUs are neutral in terms of hospitalization rates and adverse cardiovascular events in patients with CHF, no standard RCT of glimepiride has been conducted to study its effect on the prognosis of patients with T2D and confirmed CHF. Glimepiride inhibits soluble epoxide hydrolase (sEH), thus reducing epoxyeicosatrienoic acid (EET) degradation . Increased EET production exerts protective effects on the heart, indicating the potential cardiovascular effect of glimepiride.

This retrospective cohort study aimed to evaluate the effects of glimepiride on the clinical outcomes of patients with T2D and CHF and provide theoretical evidence for the clinical application of glimepiride in these patients.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic heart failure (>6 months duration, according to 2021 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure)
  • Reduced ejection fraction defined as LVEF < 50%
  • N-terminal pro-brain natriuretic peptide (NT-proBNP) level: >125 pg/mL
  • NYHA-class II/III/IV with stable symptoms for at least the past 3 months
  • Type 2 diabetes (according to the Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022)

Exclusion criteria

  • Those who did not meet the diagnostic criteria
  • Lacked echocardiographic and NT-proBNP data
  • Used sulfonylureas other than glimepiride were excluded

Treatment and study plan

Glimepiride

Drug

Glimepiride 1-4 mg/day

Other names: Amaryl

Primary outcomes

  1. Cardiovascular mortality

    Time frame: 5 years

    Numbers and dates of death due to cardiovascular diseases in each group

  2. Hospitalizations and emergency visits for heart failure

    Time frame: 5 years

    Numbers and dates of hospitalizations and emergency for heart failure

Secondary outcomes

  1. All-cause mortality

    Time frame: 5 years

    Numbers and dates of death in each group

  2. Hospitalizations for acute myocardial infarction or stroke

    Time frame: 5 years

    Numbers and dates of hospitalizations for acute myocardial infarction or stroke

Sponsors and collaborators

Lead sponsor

Dao Wen Wang

Other

Collaborators

  • Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Registry information

Acronym: EGPT2D&CHF

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2022
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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