Cardiac SurgeryNCT05374655
Outcomes Study of Glycosylated Hemoglobin Control in Cox-Maze IV During Cardiac Surgery
A study of Cardiac Surgery, run by Kun Hua at 1 site in China.
Trial summary
In recent years, a growing body of research has shown that diabetes plays an important role in the development and recurrence of atrial fibrillation. How to achieve the treatment and prevention of recurrence of atrial fibrillation through appropriate blood glucose control is the current focus of clinical research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2022to 31 Aug 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Elective cardiac surgery
- A clear diagnosis of diabetes mellitus, and HbA1c ≥ 7.5% at the time of initial diagnosis and treatment
- Preoperative combination of persistent or long-term persistent atrial fibrillation
Who cannot join
- Emergency surgery or limited-term surgery
- Previous cardiac surgery
- Left atrial diameter > 65 mm
- Serum creatine > 1.8 mg/dL
- Previous severe liver disease
- Pregnant or planning to become pregnant
- Have a malignant tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Controlled Clinical Study of Preoperative Glycosylated Hemoglobin Control Strategies on the Effectiveness of Cox-Maze IV Procedure for Atrial Fibrillation During Cardiac Surgery
In recent years, a growing body of research has shown that diabetes plays an important role in the development and recurrence of atrial fibrillation. How to achieve the treatment and prevention of recurrence of atrial fibrillation through appropriate blood glucose control is the current focus of clinical research. Glycosylated hemoglobin (HbA1c) is the product of a non-enzymatic reaction in which hemoglobin in red blood cells is combined with sugars in the serum (mainly glucose). The purpose of this multicenter, randomized controlled study is to compare the effects of different glycosylated hemoglobin control strategies on the effectiveness of Cox-Maze IV procedure for atrial fibrillation during cardiac surgery.
- Conditions
- Cardiac Surgery
- Being tested
- Preoperative blood glucose control
- Keywords
- Cardiac Surgery, Atrial Fibrillation, Glycosylated Hemoglobin, Cox-Maze IV
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative blood glucose controlOther
Patients included in this group, under the guidance of endocrinologists, develop hypoglycemic strategies for patients, follow up and guide patients to take medication, review HbA1c levels after 6 weeks, perform surgical treatment if they meet preoperative HbA1c<7.5%, continue hypoglycemic therapy if still above standards, and administer drugs according to the corresponding type of heart disease during this period.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative blood glucose control | Experimental | Under the guidance of endocrinologists, the patient's hypoglycemic strategy is formulated, follow-up guidance is guided by the patient to take the drug, the HbA1c level is reviewed after 6 weeks, the preoperative HbA1c < 7.5% is performed surgically, and if it is still above the standard, the hypoglycemic therapy is continued, during which the patient is administered according to the corresponding heart disease type. Receives: Other: Preoperative blood glucose control |
| Preoperative blood glucose uncontrol | No intervention | Patients included in this group ≥ 7.5% preoperative HbA1c and underwent surgery directly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of atrial fibrillation recurrence
Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds
Measured: one year post operative
Secondary outcomes (2)
Rate of atrial fibrillation recurrence
Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds
Measured: 6 months post operative
All-cause Mortality
All-cause mortality identified during one-year follow-up
Measured: one year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start15 May 2022
- Primary completion7 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kun Hua
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Peking University International Hospital, Beijing Huaxin Hospital
- Responsible party
- Sponsor-investigator, Kun Hua, Beijing Anzhen Hospital
- Investigators
- Kun Hua, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374655
- Sponsor's protocol ID
- blank
- Status last verified
- Apr 2023
- First submitted
- 10 May 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Clinical Study of Preoperative Glycosylated Hemoglobin Control Strategies on the Effectiveness of Cox-Maze IV Procedure for Atrial Fibrillation During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05374655
- Acronym / sponsor ID
- blank
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac Surgery, Atrial Fibrillation, Glycosylated Hemoglobin, Cox-Maze IV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Kun HuaUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Peking University International Hospital, Beijing Huaxin Hospital
- Study start
- 15 May 2022 (actual)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 16 May 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.
In recent years, a growing body of research has shown that diabetes plays an important role in the development and recurrence of atrial fibrillation. How to achieve the treatment and prevention of recurrence of atrial fibrillation through appropriate blood glucose control is the current focus of clinical research. Glycosylated hemoglobin (HbA1c) is the product of a non-enzymatic reaction in which hemoglobin in red blood cells is combined with sugars in the serum (mainly glucose). The purpose of this multicenter, randomized controlled study is to compare the effects of different glycosylated hemoglobin control strategies on the effectiveness of Cox-Maze IV procedure for atrial fibrillation during cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative blood glucose control | Experimental | Other: Preoperative blood glucose controlUnder the guidance of endocrinologists, the patient's hypoglycemic strategy is formulated, follow-up guidance is guided by the patient to take the drug, the HbA1c level is reviewed after 6 weeks, the preoperative HbA1c < 7.5% is performed surgically, and if it is still above the standard, the hypoglycemic therapy is continued, during which the patient is administered according to the corresponding heart disease type. |
| Preoperative blood glucose uncontrol | No intervention | –Patients included in this group ≥ 7.5% preoperative HbA1c and underwent surgery directly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Elective cardiac surgery
- A clear diagnosis of diabetes mellitus, and HbA1c ≥ 7.5% at the time of initial diagnosis and treatment
- Preoperative combination of persistent or long-term persistent atrial fibrillation
Key exclusion criteria (7 listed)
- Emergency surgery or limited-term surgery
- Previous cardiac surgery
- Left atrial diameter > 65 mm
- Serum creatine > 1.8 mg/dL
- Previous severe liver disease
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 |
|---|---|---|
| Preoperative blood glucose controlPatients included in this group, under the guidance of endocrinologists, develop hypoglycemic strategies for patients, follow up and guide patients to take medication, review HbA1c levels after 6 weeks, perform surgical treatment if they meet preoperative HbA1c<7.5%, continue hypoglycemic therapy if still above standards, and administer drugs according to the corresponding type of heart disease during this period. | Other | Preoperative blood glucose control |
Primary outcome
Rate of atrial fibrillation recurrence
Time frame: one year post operative
Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds
2 secondary outcomes
Rate of atrial fibrillation recurrence
Time frame: 6 months post operative
All-cause Mortality
Time frame: one year post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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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.
Kun Hua study chair
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiac Surgery, run by Kun Hua 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Hua (+8615810111206, huakun0310@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of atrial fibrillation recurrence (time frame: one year post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2023.