Cardiomyopathy, Dilated Clinical Trial
Official title:
Clinical Observation on the Prognosis of Long-term Cardiac Function by Drug Withdrawal in Patients With Peripartum Cardiomyopathy With Cardiac Function Recovery
Peripartum cardiomyopathy (PPCM) is an idiopathic cardiomyopathy that occurs in late pregnancy and early postnatal period, which is mainly characterized by varying degrees of impaired ventricular systolic function and symptoms related to heart failure, and is a serious threat to maternal health. About 50% of patients can achieve complete recovery of cardiac function within 6 months after diagnosis with early standardized treatment, about 30%-40% of patients can have delayed recovery, and about 12.6% of patients have long-term impairment of cardiac function and poor prognosis. However, there are still controversies about whether and when to stop the drug after standardized treatment. The Chinese Society of Cardiovascular Disease of the Chinese Medical Association proposed in the Guidelines for the Diagnosis and Treatment of Dilated Cardiomyopathy in China that patients with PPCM should be considered for gradual withdrawal of the drug after at least 1 year of stabilization of cardiac structure and function recovery. And in the China Heart Failure and Diagnostic and Treatment Guidelines released in the same year, it is proposed that standardized heart failure therapy for patients with peripheral cardiomyopathy should be continued until at least 6 months after the left ventricular function has been fully recovered before gradual discontinuation of the drug. The American Heart Association's 2019 guidelines for perinatal cardiomyopathy remain skeptical about the timing of discontinuation, with some experts suggesting that the drug can be gradually discontinued 1-2 years after cardiac function has recovered, while others still recommend long-term use of the drug to avoid deterioration of cardiac function after discontinuation. At present, there is a lack of large-scale clinical studies on the effect of stopping standardized treatment on the long-term prognosis of PPCM patients, and clarifying whether PPCM patients can discontinue the drug and the timing of discontinuation is of great significance to the long-term prognosis of the patients and even to the rational allocation of the national healthcare resources as a whole.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 1, 2024 |
Est. primary completion date | October 10, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: Perinatal cardiomyopathy patients aged 20-45 years who meet the diagnostic criteria for perinatal cardiomyopathy, i.e.: heart failure and left ventricular systolic hypoplasia occurring in the last trimester of gestation or 5 months postpartum; no previous history of heart failure and other etiologies that could explain the heart failure; impaired left ventricular function as indicated by cardiac ultrasound: LVEF <45% and/or FS <30% or left ventricular end-diastolic internal diameter ( LVEDd) > 5.0 cm; (ii) Those who have been diagnosed with perinatal cardiomyopathy and are now receiving standardized drug therapy, and whose cardiac function has not yet recovered, and whose enrollment time is not more than 1 year from the time of diagnosis. Exclusion Criteria: (i) Those with a previous history of severe organic valvular disease; (ii) Those with a previous history of diabetes mellitus, chronic hypertension and thyroid disease; - Those with history of congenital heart disease, ischemic cardiomyopathy and other cardiomyopathies; ? Those with severe infections and impaired liver and kidney functions (eGFR <30ml/min/1.73m2, or transaminases more than 5 times higher than the upper limit of normal values); ? Those with previous persistent atrial, supraventricular or ventricular arrhythmia and have to be treated with anti-arrhythmic drugs for a long time; (vi) Those with serious adverse reactions and contraindications to heart failure therapeutic drugs. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Qilu Hospital of Shandong University |
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Li W, Li H, Long Y. Clinical Characteristics and Long-term Predictors of Persistent Left Ventricular Systolic Dysfunction in Peripartum Cardiomyopathy. Can J Cardiol. 2016 Mar;32(3):362-8. doi: 10.1016/j.cjca.2015.07.733. Epub 2015 Aug 15. — View Citation
Otani K, Tokudome T, Kamiya CA, Mao Y, Nishimura H, Hasegawa T, Arai Y, Kaneko M, Shioi G, Ishida J, Fukamizu A, Osaki T, Nagai-Okatani C, Minamino N, Ensho T, Hino J, Murata S, Takegami M, Nishimura K, Kishimoto I, Miyazato M, Harada-Shiba M, Yoshimatsu J, Nakao K, Ikeda T, Kangawa K. Deficiency of Cardiac Natriuretic Peptide Signaling Promotes Peripartum Cardiomyopathy-Like Remodeling in the Mouse Heart. Circulation. 2020 Feb 18;141(7):571-588. doi: 10.1161/CIRCULATIONAHA.119.039761. Epub 2019 Oct 31. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | deterioration in cardiac function within 1 year of the subgroup study | (i) a decrease in LVEF <10% and LVEF <50%; (ii) an increase in LVEDV of more than 10% and above the normal range; (iii) a 2-fold increase in NT-proBNP concentration of more than 400 ng/L; and (iv) the development of signs and symptoms of heart failure) | 1 year | |
Secondary | patient cardiovascular accidents, rehospitalization-related adverse events | sustained arrhythmias, difficult-to-control hypertension, rehospitalization, and death | 1 year |
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