xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06039072</url>
    </required_header>
    <id_info>
      <org_study_id>KYLL-2020(KS)-685</org_study_id>
      <nct_id>NCT06039072</nct_id>
    </id_info>
    <brief_title>Clinical Observation of Long-term Cardiac Function Prognosis in Patients With PPCM Who Have Recovered Cardiac Function</brief_title>
    <official_title>Clinical Observation on the Prognosis of Long-term Cardiac Function by Drug Withdrawal in Patients With Peripartum Cardiomyopathy With Cardiac Function Recovery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qilu Hospital of Shandong University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Peripartum cardiomyopathy (PPCM) is an idiopathic cardiomyopathy that occurs in late&#xD;
        pregnancy and early postnatal period, which is mainly characterized by varying degrees of&#xD;
        impaired ventricular systolic function and symptoms related to heart failure, and is a&#xD;
        serious threat to maternal health. About 50% of patients can achieve complete recovery of&#xD;
        cardiac function within 6 months after diagnosis with early standardized treatment, about&#xD;
        30%-40% of patients can have delayed recovery, and about 12.6% of patients have long-term&#xD;
        impairment of cardiac function and poor prognosis. However, there are still controversies&#xD;
        about whether and when to stop the drug after standardized treatment. The Chinese Society of&#xD;
        Cardiovascular Disease of the Chinese Medical Association proposed in the Guidelines for the&#xD;
        Diagnosis and Treatment of Dilated Cardiomyopathy in China that patients with PPCM should be&#xD;
        considered for gradual withdrawal of the drug after at least 1 year of stabilization of&#xD;
        cardiac structure and function recovery. And in the China Heart Failure and Diagnostic and&#xD;
        Treatment Guidelines released in the same year, it is proposed that standardized heart&#xD;
        failure therapy for patients with peripheral cardiomyopathy should be continued until at&#xD;
        least 6 months after the left ventricular function has been fully recovered before gradual&#xD;
        discontinuation of the drug. The American Heart Association's 2019 guidelines for perinatal&#xD;
        cardiomyopathy remain skeptical about the timing of discontinuation, with some experts&#xD;
        suggesting that the drug can be gradually discontinued 1-2 years after cardiac function has&#xD;
        recovered, while others still recommend long-term use of the drug to avoid deterioration of&#xD;
        cardiac function after discontinuation. At present, there is a lack of large-scale clinical&#xD;
        studies on the effect of stopping standardized treatment on the long-term prognosis of PPCM&#xD;
        patients, and clarifying whether PPCM patients can discontinue the drug and the timing of&#xD;
        discontinuation is of great significance to the long-term prognosis of the patients and even&#xD;
        to the rational allocation of the national healthcare resources as a whole.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To clarify the effects of continuing standardized therapy and discontinuing standardized drug&#xD;
        therapy on long-term cardiac function in patients with perinatal cardiomyopathy 1 year after&#xD;
        cardiac function has been restored and stabilized, and to provide more theoretical and&#xD;
        clinical bases for the therapeutic regimen of patients with perinatal cardiomyopathy after&#xD;
        cardiac function is restored.&#xD;
  &#xD;
        After diagnosis, patients received standardized heart failure treatment: according to the&#xD;
        perinatal cardiomyopathy diagnosis and treatment guidelines of the Cardiovascular Disease&#xD;
        Branch of the Chinese Medical Association and the American Heart Association, standardized&#xD;
        heart failure treatment and symptomatic treatment were carried out according to the&#xD;
        individualized differences of the patients, and for those who developed the disease in&#xD;
        pregnancy, non-contraindicated medication was applied before delivery, and the appropriate&#xD;
        mode of delivery was selected according to the gestation week and the cardiac function of the&#xD;
        patient and the condition of the fetus, and the patients were given a comprehensive decision&#xD;
        on the treatment plan by our hospital and the cardiologists and obstetricians of the&#xD;
        collaborating hospitals. Cardiologists and obstetricians from our hospital and collaborating&#xD;
        hospitals made comprehensive decisions on the treatment plan for the patients. The&#xD;
        cardiologists and obstetricians of our hospital and the collaborating hospitals will make a&#xD;
        comprehensive decision on the treatment plan of the patients. We will also assess whether the&#xD;
        patients are suitable for breastfeeding, and choose non-contraindicated drugs and drugs with&#xD;
        low milk concentration for breastfeeding, and standardize heart failure treatment as soon as&#xD;
        possible after breastfeeding is finished; and for the non-breastfeeding patients, we will&#xD;
        carry out the anti-heart failure treatment, applying the drugs such as ACEI/ARB, MRA and&#xD;
        β-blocker as early as possible, and adjusting the dosage gradually according to the principle&#xD;
        of individualization.&#xD;
  &#xD;
        Treatment regimen for subjects in the discontinuation group: subjects received a combination&#xD;
        of ACEI/ARBs, β-blockers, MRAs and diuretics during the standardized treatment phase, and&#xD;
        after recovery of cardiac function, in order to avoid adverse effects on cardiac function&#xD;
        caused by sudden withdrawal of medication, the medication was gradually discontinued in&#xD;
        accordance with the protocol.&#xD;
  &#xD;
        The completed case observation forms from each test center were retrieved after review by the&#xD;
        supervisors and handed over to the main responsible unit (i.e., Qilu Hospital of Shandong&#xD;
        University) for data processing. Data on the case report forms were entered in double copies&#xD;
        by two persons, and the database was locked after verification to confirm that there were no&#xD;
        errors. Measurement data were described by mean and standard deviation, and count data were&#xD;
        described by number of cases and percentage. SPSS.23.0 statistical software was applied to&#xD;
        statistically analyze the intention-to-treat set and the protocol-compliant set,&#xD;
        respectively. The demographic characteristics of the enrolled cases in the two sets were&#xD;
        first analyzed at baseline to examine the balance and comparability of the two sets. Then the&#xD;
        effectiveness indicators and safety indicators of the two groups were compared.&#xD;
  &#xD;
        For each index in the UCG, ECG, and a number of indicators such as blood pressure and heart&#xD;
        rate between the experimental group and the control group; quantitative information was&#xD;
        compared using the t-test for two-sample comparisons in a paired group design. At the same&#xD;
        time, subgroup analyses were set up based on the NT-proBNP values of the patients and the&#xD;
        time required for recovery of cardiac function, and univariate and multivariate statistical&#xD;
        analyses were performed, and the primary endpoints were analyzed using the Kaplan-Meier&#xD;
        survival curves with the log-rank-sum test, and the rank-sum tests for the group-designed&#xD;
        two-sample comparisons were used for the NYHA classification and KCCQ scores. All statistical&#xD;
        tests were two-sided, and a p-value less than or equal to 0.05 was considered statistically&#xD;
        significant for the differences tested.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>3 Years</target_duration>
    <primary_outcome>
      <measure>deterioration in cardiac function within 1 year of the subgroup study</measure>
      <time_frame>1 year</time_frame>
      <description>(i) a decrease in LVEF &lt;10% and LVEF &lt;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)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>patient cardiovascular accidents, rehospitalization-related adverse events</measure>
      <time_frame>1 year</time_frame>
      <description>sustained arrhythmias, difficult-to-control hypertension, rehospitalization, and death</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Cardiomyopathy, Dilated</condition>
    <arm_group>
      <arm_group_label>Subjects in the withdrawal group</arm_group_label>
      <description>Subjects received a combination of ACEI/ARB analogues, beta-blockers, MRA analogues, and diuretics during the standardized treatment phase, and after their cardiac function was restored, in order to avoid adverse effects on patients' cardiac function due to sudden withdrawal of drugs, the drugs were withdrawn according to a program to gradually stop the drug</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Subjects in the continuing medication group</arm_group_label>
      <description>Subjects received a combination of ACEI/ARB analogues, beta-blockers, MRA analogues, and diuretics during the standardized treatment phase, and were continued on the original regimen after their cardiac function recovered</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Patients with cardiac function recovered for more than one year and discontinued were in the discontinuation group.</intervention_name>
      <description>Among the patients with perinatal cardiomyopathy who were included in the study, their heart function returned to normal in 1 year after receiving standardized treatment, and then after another 1 year of standardized treatment to respect the patients' individual wishes, fully inform the patients of the relevant information and potential risks, including the possibility of deterioration of heart function after discontinuation of the medication, and only after obtaining the patients' informed consent and signing the informed consent form could they be included in the discontinuation group, and the rest were in the non-discontinuation group.</description>
      <arm_group_label>Subjects in the withdrawal group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples were collected for NT-proBNP values, routine blood tests (white blood cell&#xD;
        count, hemoglobin, red blood cell count, platelet count, hematocrit), blood biochemistry&#xD;
        (alanine aminotransferase, glutamine aminotransferase, urea nitrogen, creatinine, albumin,&#xD;
        lipids, electrolytes, etc.), inflammatory markers (C-reactive protein, calcitonin), thyroid&#xD;
        function (FT3, FT4, TSH, etc.), and markers of myocardial injury (troponin I, troponin T,&#xD;
        creatine kinase isozymes, D-dimer, etc.), as well as genetic testing.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Source Clinical case collection of peripartum cardiomyopathy in multiple hospitals and&#xD;
          recruitment of patients with peripartum cardiomyopathy，with recovery of cardiac function&#xD;
          after standardized treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Perinatal cardiomyopathy patients aged 20-45 years who meet the diagnostic criteria for&#xD;
          perinatal cardiomyopathy, i.e.: heart failure and left ventricular systolic hypoplasia&#xD;
          occurring in the last trimester of gestation or 5 months postpartum; no previous history of&#xD;
          heart failure and other etiologies that could explain the heart failure; impaired left&#xD;
          ventricular function as indicated by cardiac ultrasound: LVEF &lt;45% and/or FS &lt;30% or left&#xD;
          ventricular end-diastolic internal diameter ( LVEDd) &gt; 5.0 cm; (ii) Those who have been&#xD;
          diagnosed with perinatal cardiomyopathy and are now receiving standardized drug therapy,&#xD;
          and whose cardiac function has not yet recovered, and whose enrollment time is not more&#xD;
          than 1 year from the time of diagnosis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (i) Those with a previous history of severe organic valvular disease; (ii) Those with a&#xD;
          previous history of diabetes mellitus, chronic hypertension and thyroid disease;&#xD;
  &#xD;
            -  Those with history of congenital heart disease, ischemic cardiomyopathy and other&#xD;
               cardiomyopathies; ④ Those with severe infections and impaired liver and kidney&#xD;
               functions (eGFR &lt;30ml/min/1.73m2, or transaminases more than 5 times higher than the&#xD;
               upper limit of normal values); ⑤ Those with previous persistent atrial,&#xD;
               supraventricular or ventricular arrhythmia and have to be treated with anti-arrhythmic&#xD;
               drugs for a long time; (vi) Those with serious adverse reactions and contraindications&#xD;
               to heart failure therapeutic drugs.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Peripartum cardiomyopathy (PPCM) is an idiopathic cardiomyopathy that occurs in late pregnancy and the early postnatal period</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiaoping ji</last_name>
      <role>Study Chair</role>
      <affiliation>Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jie Xiao</last_name>
      <phone>18560089160</phone>
      <email>chrisy-4619.202@163.com</email>
    </overall_contact>
    <reference>
      <citation>Bauersachs J, Konig T, van der Meer P, Petrie MC, Hilfiker-Kleiner D, Mbakwem A, Hamdan R, Jackson AM, Forsyth P, de Boer RA, Mueller C, Lyon AR, Lund LH, Piepoli MF, Heymans S, Chioncel O, Anker SD, Ponikowski P, Seferovic PM, Johnson MR, Mebazaa A, Sliwa K. Pathophysiology, diagnosis and management of peripartum cardiomyopathy: a position statement from the Heart Failure Association of the European Society of Cardiology Study Group on peripartum cardiomyopathy. Eur J Heart Fail. 2019 Jul;21(7):827-843. doi: 10.1002/ejhf.1493. Epub 2019 Jun 27.</citation>
      <PMID>31243866</PMID>
    </reference>
    <reference>
      <citation>Barasa A, Goloskokova V, Ladfors L, Patel H, Schaufelberger M. Symptomatic recovery and pharmacological management in a clinical cohort with peripartum cardiomyopathy. J Matern Fetal Neonatal Med. 2018 May;31(10):1342-1349. doi: 10.1080/14767058.2017.1317341. Epub 2017 May 2.</citation>
      <PMID>28462600</PMID>
    </reference>
    <reference>
      <citation>Biteker M, Ozlek B, Ozlek E, Cil C, Celik O, Dogan V, Basaran O. Predictors of early and delayed recovery in peripartum cardiomyopathy: a prospective study of 52 Patients. J Matern Fetal Neonatal Med. 2020 Feb;33(3):390-397. doi: 10.1080/14767058.2018.1494146. Epub 2018 Sep 27.</citation>
      <PMID>29945487</PMID>
    </reference>
    <reference>
      <citation>Davis MB, Arany Z, McNamara DM, Goland S, Elkayam U. Peripartum Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jan 21;75(2):207-221. doi: 10.1016/j.jacc.2019.11.014.</citation>
      <PMID>31948651</PMID>
    </reference>
    <reference>
      <citation>Hilfiker-Kleiner D, Kaminski K, Podewski E, Bonda T, Schaefer A, Sliwa K, Forster O, Quint A, Landmesser U, Doerries C, Luchtefeld M, Poli V, Schneider MD, Balligand JL, Desjardins F, Ansari A, Struman I, Nguyen NQ, Zschemisch NH, Klein G, Heusch G, Schulz R, Hilfiker A, Drexler H. A cathepsin D-cleaved 16 kDa form of prolactin mediates postpartum cardiomyopathy. Cell. 2007 Feb 9;128(3):589-600. doi: 10.1016/j.cell.2006.12.036.</citation>
      <PMID>17289576</PMID>
    </reference>
    <reference>
      <citation>Pearson GD, Veille JC, Rahimtoola S, Hsia J, Oakley CM, Hosenpud JD, Ansari A, Baughman KL. Peripartum cardiomyopathy: National Heart, Lung, and Blood Institute and Office of Rare Diseases (National Institutes of Health) workshop recommendations and review. JAMA. 2000 Mar 1;283(9):1183-8. doi: 10.1001/jama.283.9.1183.</citation>
      <PMID>10703781</PMID>
    </reference>
    <reference>
      <citation>Halliday BP, Wassall R, Lota AS, Khalique Z, Gregson J, Newsome S, Jackson R, Rahneva T, Wage R, Smith G, Venneri L, Tayal U, Auger D, Midwinter W, Whiffin N, Rajani R, Dungu JN, Pantazis A, Cook SA, Ware JS, Baksi AJ, Pennell DJ, Rosen SD, Cowie MR, Cleland JGF, Prasad SK. Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial. Lancet. 2019 Jan 5;393(10166):61-73. doi: 10.1016/S0140-6736(18)32484-X. Epub 2018 Nov 11.</citation>
      <PMID>30429050</PMID>
    </reference>
    <reference>
      <citation>Isogai T, Kamiya CA. Worldwide Incidence of Peripartum Cardiomyopathy and Overall Maternal Mortality. Int Heart J. 2019 May 30;60(3):503-511. doi: 10.1536/ihj.18-729. Epub 2019 Apr 25.</citation>
      <PMID>31019181</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>31665900</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>26586094</PMID>
    </reference>
    <reference>
      <citation>Shani H, Kuperstein R, Berlin A, Arad M, Goldenberg I, Simchen MJ. Peripartum cardiomyopathy - risk factors, characteristics and long-term follow-up. J Perinat Med. 2015 Jan;43(1):95-101. doi: 10.1515/jpm-2014-0086.</citation>
      <PMID>24887948</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</mesh_term>
      <mesh_term>Cardiomyopathy, Dilated</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06039072
  org study id: KYLL-2020(KS)-685
  nct id: NCT06039072
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: deterioration in cardiac function within 1 year of the subgroup study
  time frame: 1 year
  description: (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)
  measure: patient cardiovascular accidents, rehospitalization-related adverse events
  time frame: 1 year
  description: sustained arrhythmias, difficult-to-control hypertension, rehospitalization, and death
  arm group label: Subjects in the withdrawal group
  description: Subjects received a combination of ACEI/ARB analogues, beta-blockers, MRA analogues, and diuretics during the standardized treatment phase, and after their cardiac function was restored, in order to avoid adverse effects on patients' cardiac function due to sudden withdrawal of drugs, the drugs were withdrawn according to a program to gradually stop the drug
  arm group label: Subjects in the continuing medication group
  description: Subjects received a combination of ACEI/ARB analogues, beta-blockers, MRA analogues, and diuretics during the standardized treatment phase, and were continued on the original regimen after their cardiac function recovered
  intervention type: Drug
  intervention name: Patients with cardiac function recovered for more than one year and discontinued were in the discontinuation group.
  description: Among the patients with perinatal cardiomyopathy who were included in the study, their heart function returned to normal in 1 year after receiving standardized treatment, and then after another 1 year of standardized treatment to respect the patients' individual wishes, fully inform the patients of the relevant information and potential risks, including the possibility of deterioration of heart function after discontinuation of the medication, and only after obtaining the patients' informed consent and signing the informed consent form could they be included in the discontinuation group, and the rest were in the non-discontinuation group.
  arm group label: Subjects in the withdrawal group
  Blood samples were collected for NT-proBNP values, routine blood tests (white blood cell
        count, hemoglobin, red blood cell count, platelet count, hematocrit), blood biochemistry
        (alanine aminotransferase, glutamine aminotransferase, urea nitrogen, creatinine, albumin,
        lipids, electrolytes, etc.), inflammatory markers (C-reactive protein, calcitonin), thyroid
        function (FT3, FT4, TSH, etc.), and markers of myocardial injury (troponin I, troponin T,
        creatine kinase isozymes, D-dimer, etc.), as well as genetic testing.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Peripartum cardiomyopathy (PPCM) is an idiopathic cardiomyopathy that occurs in late pregnancy and the early postnatal period
  minimum age: 20 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Xiaoping ji
  role: Study Chair
  affiliation: Qilu Hospital of Shandong University
  last name: Jie Xiao
  phone: 18560089160
  email: chrisy-4619.202@163.com
  citation: Bauersachs J, Konig T, van der Meer P, Petrie MC, Hilfiker-Kleiner D, Mbakwem A, Hamdan R, Jackson AM, Forsyth P, de Boer RA, Mueller C, Lyon AR, Lund LH, Piepoli MF, Heymans S, Chioncel O, Anker SD, Ponikowski P, Seferovic PM, Johnson MR, Mebazaa A, Sliwa K. Pathophysiology, diagnosis and management of peripartum cardiomyopathy: a position statement from the Heart Failure Association of the European Society of Cardiology Study Group on peripartum cardiomyopathy. Eur J Heart Fail. 2019 Jul;21(7):827-843. doi: 10.1002/ejhf.1493. Epub 2019 Jun 27.
  PMID: 31243866
  citation: Barasa A, Goloskokova V, Ladfors L, Patel H, Schaufelberger M. Symptomatic recovery and pharmacological management in a clinical cohort with peripartum cardiomyopathy. J Matern Fetal Neonatal Med. 2018 May;31(10):1342-1349. doi: 10.1080/14767058.2017.1317341. Epub 2017 May 2.
  PMID: 28462600
  citation: Biteker M, Ozlek B, Ozlek E, Cil C, Celik O, Dogan V, Basaran O. Predictors of early and delayed recovery in peripartum cardiomyopathy: a prospective study of 52 Patients. J Matern Fetal Neonatal Med. 2020 Feb;33(3):390-397. doi: 10.1080/14767058.2018.1494146. Epub 2018 Sep 27.
  PMID: 29945487
  citation: Davis MB, Arany Z, McNamara DM, Goland S, Elkayam U. Peripartum Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jan 21;75(2):207-221. doi: 10.1016/j.jacc.2019.11.014.
  PMID: 31948651
  citation: Hilfiker-Kleiner D, Kaminski K, Podewski E, Bonda T, Schaefer A, Sliwa K, Forster O, Quint A, Landmesser U, Doerries C, Luchtefeld M, Poli V, Schneider MD, Balligand JL, Desjardins F, Ansari A, Struman I, Nguyen NQ, Zschemisch NH, Klein G, Heusch G, Schulz R, Hilfiker A, Drexler H. A cathepsin D-cleaved 16 kDa form of prolactin mediates postpartum cardiomyopathy. Cell. 2007 Feb 9;128(3):589-600. doi: 10.1016/j.cell.2006.12.036.
  PMID: 17289576
  citation: Pearson GD, Veille JC, Rahimtoola S, Hsia J, Oakley CM, Hosenpud JD, Ansari A, Baughman KL. Peripartum cardiomyopathy: National Heart, Lung, and Blood Institute and Office of Rare Diseases (National Institutes of Health) workshop recommendations and review. JAMA. 2000 Mar 1;283(9):1183-8. doi: 10.1001/jama.283.9.1183.
  PMID: 10703781
  citation: Halliday BP, Wassall R, Lota AS, Khalique Z, Gregson J, Newsome S, Jackson R, Rahneva T, Wage R, Smith G, Venneri L, Tayal U, Auger D, Midwinter W, Whiffin N, Rajani R, Dungu JN, Pantazis A, Cook SA, Ware JS, Baksi AJ, Pennell DJ, Rosen SD, Cowie MR, Cleland JGF, Prasad SK. Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial. Lancet. 2019 Jan 5;393(10166):61-73. doi: 10.1016/S0140-6736(18)32484-X. Epub 2018 Nov 11.
  PMID: 30429050
  citation: Isogai T, Kamiya CA. Worldwide Incidence of Peripartum Cardiomyopathy and Overall Maternal Mortality. Int Heart J. 2019 May 30;60(3):503-511. doi: 10.1536/ihj.18-729. Epub 2019 Apr 25.
  PMID: 31019181
  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.
  PMID: 31665900
  citation: 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.
  PMID: 26586094
  citation: Shani H, Kuperstein R, Berlin A, Arad M, Goldenberg I, Simchen MJ. Peripartum cardiomyopathy - risk factors, characteristics and long-term follow-up. J Perinat Med. 2015 Jan;43(1):95-101. doi: 10.1515/jpm-2014-0086.
  PMID: 24887948
  responsible party type: Sponsor
  mesh term: Cardiomyopathies
  mesh term: Cardiomyopathy, Dilated
  sharing ipd: No