Chronic Heart FailureEGPT2D&CHFNCT05538819
The Effects of Glimepiride in Patients With Type 2 Diabetes and Chronic Heart Failure
An observational study of Chronic Heart Failure and Type 2 Diabetes, run by Dao Wen Wang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Type 2 Diabetes, Cardiovascular Mortality
- What is being tested?
- Glimepiride
- How many people
- 1,018 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 Jul 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- Those who did not meet the diagnostic criteria
- Lacked echocardiographic and NT-proBNP data
- Used sulfonylureas other than glimepiride were excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Glimepiride
- Keywords
- glimepiride, type 2 diabetes, chronic heart failure, cardiovascular mortality
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlimepirideDrug
Also called Amaryl
Glimepiride 1-4 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Glimepiride group | 509 patients aged >18 years with T2D and CHF had continuous glimepiride use (1-4 mg/day). Receives: Drug: Glimepiride | |
| Non-glimepiride group | 509 patients aged >18 years with T2D and CHF had no glimepiride use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Numbers and dates of death due to cardiovascular diseases in each group
Measured: 5 years
Hospitalizations and emergency visits for heart failure
Numbers and dates of hospitalizations and emergency for heart failure
Measured: 5 years
Secondary outcomes (2)
All-cause mortality
Numbers and dates of death in each group
Measured: 5 years
Hospitalizations for acute myocardial infarction or stroke
Numbers and dates of hospitalizations for acute myocardial infarction or stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Jun 2017
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,018 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Dao Wen Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Responsible party
- Sponsor-investigator, Dao Wen Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538819
- Sponsor's protocol ID
- TJ-T2D&CHF-Glimepiride
- Acronym
- EGPT2D&CHF
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are working hard to have IPD sharing plan and are willing to share it with other researchers.
Publications
He W, Yuan G, Han Y, Yan Y, Li G, Zhao C, Shen J, Jiang X, Chen C, Ni L, Wang DW. Glimepiride Use is Associated with Reduced Cardiovascular Mortality in Patients with Type 2 Diabetes and Chronic Heart Failure: A Prospective Cohort Study. Eur J Prev Cardiol. 2022 Dec 27:zwac312. doi: 10.1093/eurjpc/zwac312. Online ahead of print.
PubMed 36573717
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Glimepiride in Patients With Type 2 Diabetes and Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05538819
- Acronym / sponsor ID
- EGPT2D&CHF / TJ-T2D&CHF-Glimepiride
- Keywords
- glimepiride, type 2 diabetes, chronic heart failure, cardiovascular mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- Dao Wen WangUniversity, hospital or other
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glimepiride group | – | Drug: Glimepiride509 patients aged >18 years with T2D and CHF had continuous glimepiride use (1-4 mg/day). |
| Non-glimepiride group | – | –509 patients aged >18 years with T2D and CHF had no glimepiride use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Those who did not meet the diagnostic criteria
- Lacked echocardiographic and NT-proBNP data
- Used sulfonylureas other than glimepiride were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlimepirideAlso: AmarylGlimepiride 1-4 mg/day | Drug | Glimepiride group |
Primary outcome
Cardiovascular mortality
Time frame: 5 years
Numbers and dates of death due to cardiovascular diseases in each group
Hospitalizations and emergency visits for heart failure
Time frame: 5 years
Numbers and dates of hospitalizations and emergency for heart failure
2 secondary outcomes
All-cause mortality
Time frame: 5 years
Hospitalizations for acute myocardial infarction or stroke
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 36573717He W, Yuan G, Han Y, Yan Y, Li G, Zhao C, Shen J, Jiang X, Chen C, Ni L, Wang DW. Glimepiride Use is Associated with Reduced Cardiovascular Mortality in Patients with Type 2 Diabetes and Chronic Heart Failure: A Prospective Cohort Study. Eur J Prev Cardiol. 2022 Dec 27:zwac312. doi: 10.1093/eurjpc/zwac312. Online ahead of print.
- Individual participant dataSharing planned: Undecided. We are working hard to have IPD sharing plan and are willing to share it with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure and Type 2 Diabetes, run by Dao Wen Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.