Clinical Observation of Long-term Cardiac Function Prognosis in Patients With PPCM Who Have Recovered Cardiac Function

NCT06039072 | Unknown

• 1 other identifier: KYLL-2020(KS)-685
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cardiomyopathy, Dilated

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• patient cardiovascular accidents, rehospitalization-related adverse events

  1 year

Study Arms (2)

Subjects in the withdrawal group

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

Drug: Patients with cardiac function recovered for more than one year and discontinued were in the discontinuation group.

Subjects in the continuing medication group

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

Interventions

Patients with cardiac function recovered for more than one year and discontinued were in the discontinuation group. DRUG

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.

Subjects in the withdrawal group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Peripartum cardiomyopathy (PPCM) is an idiopathic cardiomyopathy that occurs in late pregnancy and the early postnatal period
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Source Clinical case collection of peripartum cardiomyopathy in multiple hospitals and recruitment of patients with peripartum cardiomyopathy，with recovery of cardiac function after standardized treatment.

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xiaoping ji

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Jie Xiao

CONTACT

18560089160; chrisy-4619.202@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: October 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: December 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share