To clarify the effects of continuing standardized therapy and discontinuing standardized drug therapy on long-term cardiac function in patients with perinatal cardiomyopathy 1 year after cardiac function has been restored and stabilized, and to provide more theoretical and clinical bases for the therapeutic regimen of patients with perinatal cardiomyopathy after cardiac function is restored.
After diagnosis, patients received standardized heart failure treatment: according to the perinatal cardiomyopathy diagnosis and treatment guidelines of the Cardiovascular Disease Branch of the Chinese Medical Association and the American Heart Association, standardized heart failure treatment and symptomatic treatment were carried out according to the individualized differences of the patients, and for those who developed the disease in pregnancy, non-contraindicated medication was applied before delivery, and the appropriate mode of delivery was selected according to the gestation week and the cardiac function of the patient and the condition of the fetus, and the patients were given a comprehensive decision on the treatment plan by our hospital and the cardiologists and obstetricians of the collaborating hospitals. Cardiologists and obstetricians from our hospital and collaborating hospitals made comprehensive decisions on the treatment plan for the patients. The cardiologists and obstetricians of our hospital and the collaborating hospitals will make a comprehensive decision on the treatment plan of the patients. We will also assess whether the patients are suitable for breastfeeding, and choose non-contraindicated drugs and drugs with low milk concentration for breastfeeding, and standardize heart failure treatment as soon as possible after breastfeeding is finished; and for the non-breastfeeding patients, we will carry out the anti-heart failure treatment, applying the drugs such as ACEI/ARB, MRA and β-blocker as early as possible, and adjusting the dosage gradually according to the principle of individualization.
Treatment regimen for subjects in the discontinuation group: subjects received a combination of ACEI/ARBs, β-blockers, MRAs and diuretics during the standardized treatment phase, and after recovery of cardiac function, in order to avoid adverse effects on cardiac function caused by sudden withdrawal of medication, the medication was gradually discontinued in accordance with the protocol.
The completed case observation forms from each test center were retrieved after review by the supervisors and handed over to the main responsible unit (i.e., Qilu Hospital of Shandong University) for data processing. Data on the case report forms were entered in double copies by two persons, and the database was locked after verification to confirm that there were no errors. Measurement data were described by mean and standard deviation, and count data were described by number of cases and percentage. SPSS.23.0 statistical software was applied to statistically analyze the intention-to-treat set and the protocol-compliant set, respectively. The demographic characteristics of the enrolled cases in the two sets were first analyzed at baseline to examine the balance and comparability of the two sets. Then the effectiveness indicators and safety indicators of the two groups were compared.
For each index in the UCG, ECG, and a number of indicators such as blood pressure and heart rate between the experimental group and the control group; quantitative information was compared using the t-test for two-sample comparisons in a paired group design. At the same time, subgroup analyses were set up based on the NT-proBNP values of the patients and the time required for recovery of cardiac function, and univariate and multivariate statistical analyses were performed, and the primary endpoints were analyzed using the Kaplan-Meier survival curves with the log-rank-sum test, and the rank-sum tests for the group-designed two-sample comparisons were used for the NYHA classification and KCCQ scores. All statistical tests were two-sided, and a p-value less than or equal to 0.05 was considered statistically significant for the differences tested.
