Outcomes Study of Glycosylated Hemoglobin Control in Cox-Maze IV During Cardiac Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery
• Intervention / Treatment: Other: Preoperative blood glucose control

• Study Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun Hua; Phone Number: +8615810111206; Email: huakun0310@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital
    • Contact: Zhan Peng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative blood glucose control; 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.	Other: Preoperative blood glucose control; 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.
No Intervention: Preoperative blood glucose uncontrol; Patients included in this group ≥ 7.5% preoperative HbA1c and underwent surgery directly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of atrial fibrillation recurrence	Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds	one year post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of atrial fibrillation recurrence	Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds	6 months post operative
All-cause Mortality	All-cause mortality identified during one-year follow-up	one year post operative

Collaborators and Investigators

• Sponsor: Kun Hua
• Collaborators: Peking University People's Hospital; Peking University International Hospital; Beijing Huaxin Hospital
• Investigators: Study Chair: Kun Hua, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Anticipated): June 7, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cardiac Surgery; Glycosylated Hemoglobin; Cox-Maze IV
• Other Study ID Numbers: blank

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No