Status:
UNKNOWN
Clinical Observation of Long-term Cardiac Function Prognosis in Patients With PPCM Who Have Recovered Cardiac Function
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Cardiomyopathy, Dilated
Eligibility:
FEMALE
20-45 years
Brief Summary
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 syst...
Detailed Description
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 funct...
Eligibility Criteria
Inclusion
- 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
- (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; ④ 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); ⑤ 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.
Key Trial Info
Start Date :
October 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06039072
Start Date
October 10 2023
End Date
December 1 2024
Last Update
September 28 2023
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