An observational study in Chronic Heart Failure, Type 2 Diabetes and Cardiovascular Mortality, sponsored by Dao Wen Wang. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Dao Wen Wang · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 1,018 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Dao Wen Wang is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
According to continuous glimepiride use, the patients were divided into glimepiride and non-glimepiride groups. A 1:1 propensity score matching (PSM) analysis was used to balance the confounding factors between the glimepiride treatment and clinical outcomes. The PSM cohort (509:509) was followed up using a telephone questionnaire directly or at an outpatient clinic at our cardiac center. The follow-up deadline was July 1, 2022. According to the follow-up results, the glimepiride group was subdivided into high-dose (2-4 mg/day) and low-dose (1 mg/day) groups.
Exclusion Criteria:
509 patients aged \>18 years with T2D and CHF had continuous glimepiride use (1-4 mg/day).
Drug: Glimepiride
509 patients aged \>18 years with T2D and CHF had no glimepiride use.
Glimepiride 1-4 mg/day
Also known as: Amaryl
Cardiovascular mortality
Numbers and dates of death due to cardiovascular diseases in each group
Time frame: 5 years
Hospitalizations and emergency visits for heart failure
Numbers and dates of hospitalizations and emergency for heart failure
Time frame: 5 years
All-cause mortality
Numbers and dates of death in each group
Time frame: 5 years
Hospitalizations for acute myocardial infarction or stroke
Numbers and dates of hospitalizations for acute myocardial infarction or stroke
Time frame: 5 years
Plan to share: Undecided — We are working hard to have IPD sharing plan and are willing to share it with other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dao Wen Wang