Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)

监测和治疗以预防胎儿房室传导阻滞可能很快发生(STOP BLOQ)

基本信息

  • 批准号:
    10250529
  • 负责人:
  • 金额:
    $ 72.48万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2020
  • 资助国家:
    美国
  • 起止时间:
    2020-09-01 至 2025-06-30
  • 项目状态:
    未结题

项目摘要

ABSTRACT Fetal complete (i.e., 3°) atrioventricular block (AVB), identified in the 2nd trimester in an otherwise normally developing heart, is almost universally associated with maternal anti-Ro autoantibodies and carries a high morbidity and mortality. It has been speculated that full expression of conduction disease results in orderly progression from normal rhythm (NR) to 1° AVB [prolonged AV interval assessed by echocardiogram (echo)], to 2° AVB (irregular cardiac rhythm or bradycardia), culminating in 3° AVB. Identification of a transition period, marked by an irregular rhythm and/or bradycardia, may be the only window of opportunity for treatment to restore NR. Thus, current surveillance employing weekly echos would fall short. We have now shown that daily fetal heart rate and rhythm monitoring (FHRM) by the mother with confirmation of abnormal findings by echo is feasible and affords rapid and successful treatment with no cases of AVB missed. The proposal combines expertise of fetal cardiologist Bettina F. Cuneo, MD (University of Colorado–Denver), rheumatologist Jill P. Buyon, MD (NYU School of Medicine), and 33 sites, to address the hypotheses that early treatment is critical, FHRM reduces the need for weekly echos, and surveillance can be limited to mothers with high-titer antibodies. This prospective trial involves three sequential Steps: 1) Screening for high titer anti-Ro60 or Ro52 centrally in Dr. Buyon's lab; 2) Surveillance by FHRM 3X daily and weekly echo; 3) Treatment of 2° AVB identified by FHRM confirmed by echo. FHRM supported by echo will be leveraged to affirm the efficacy of rapid treatment of 2° AVB and incidence/outcome of AV interval prolongation as well as extra-nodal disease. By identifying 850 high-titer anti-Ro pregnancies in Step 1, FHRM in Step 2, and a single arm multicenter trial in Step 3, Aim 1 will determine whether expeditious treatment of 2° AVB restores NR. Mothers detecting an abnormal FHRM confirmed to be 2° AVB will be treated in ≤12 hours of detection with a potent dual anti-inflammatory approach, dexamethasone and IVIG, the primary outcome being percentage of treated fetuses whose rhythm regresses to NR. A sample size of 30 fetuses with 2° AVB ensures at least 80% power to detect an increase in the rate of reversal to NR from 25% (historical control rate) to 50% with treatment. Women with low-titer anti-Ro will not enter the Step 2-FHRM phase, but birth ECGs will be collected. Aim 2 assesses the incidence and natural history of a fetal prolonged AV interval ≤170 milliseconds (ms). Treatment of AV intervals >170ms will also be evaluated. Aim 3 assesses the incidence and outcome of fetuses with isolated extra-nodal cardiac disease. Impact: Strong preliminary data, interdisciplinary collaboration and national expertise support our application of the NICHD “Consortium Model” Network in providing a unique opportunity to reverse inflammatory/fibrotic sequelae of anti-Ro thereby preventing lifelong disability. It is anticipated that this study will decrease 3° AVB, yield evidence-based management guidelines, set precedent for universal pre-natal screening for anti-Ro, reduce costlier echo surveillance, and empower mothers in their own health care.
摘要

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Jill P Buyon其他文献

Substantiation of trophoblast transport of maternal anti-SSA/Ro autoantibodies in fetuses with rapidly progressive cardiac injury: implications for neonatal Fc receptor blockade
母体抗 SSA/Ro 自身抗体经滋养层转运至有快速进展性心脏损伤胎儿中的证据:对新生儿 Fc 受体阻断的意义
  • DOI:
    10.1016/s2665-9913(24)00331-x
  • 发表时间:
    2025-01-01
  • 期刊:
  • 影响因子:
    16.400
  • 作者:
    Jill P Buyon;Philip M Carlucci;Bettina F Cuneo;Mala Masson;Peter Izmirly;Nalani Sachan;Justin S Brandt;Shilpi Mehta-Lee;Marc Halushka;Kristen Thomas;Melanie Fox;Colin KL Phoon;Achiau Ludomirsky;Ranjini Srinivasan;Garrett Lam;Benjamin J Wainwright;Nicola Fraser;Robert Clancy
  • 通讯作者:
    Robert Clancy
Cardiac manifestations of neonatal lupus erythematosus: guidelines to management, integrating clues from the bench and bedside
新生儿红斑狼疮的心脏表现:管理指南,整合实验台和病床旁的线索
  • DOI:
    10.1038/ncprheum1018
  • 发表时间:
    2009-03-01
  • 期刊:
  • 影响因子:
    32.700
  • 作者:
    Jill P Buyon;Robert M Clancy;Deborah M Friedman
  • 通讯作者:
    Deborah M Friedman
A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes
索马鲁肽治疗 2 型糖尿病患者的心脏病研究
  • DOI:
  • 发表时间:
    2019
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Devyn Zaminski;Amit Saxena;P. Izmirly;Jill P Buyon;H. M. Belmont
  • 通讯作者:
    H. M. Belmont

Jill P Buyon的其他文献

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{{ truncateString('Jill P Buyon', 18)}}的其他基金

Stopping Hydroxychloroquine In Elderly Lupus Disease (SHIELD)
停止使用羟氯喹治疗老年狼疮病 (SHIELD)
  • 批准号:
    10594743
  • 财政年份:
    2023
  • 资助金额:
    $ 72.48万
  • 项目类别:
HEALTH: Harnessing Epidemiology to Advance Lupus Treatment and Health
健康:利用流行病学促进狼疮治疗和健康
  • 批准号:
    10668437
  • 财政年份:
    2022
  • 资助金额:
    $ 72.48万
  • 项目类别:
Lupus Omics Cutaneous Kidney Investigative Team (LOCKIT) - Pain Supplement
狼疮组学皮肤肾脏调查小组 (LOCKIT) - 疼痛补充剂
  • 批准号:
    10861419
  • 财政年份:
    2022
  • 资助金额:
    $ 72.48万
  • 项目类别:
Lupus Omics Cutaneous Kidney Investigative Team (LOCKIT)
狼疮组学皮肤肾研究小组 (LOCKIT)
  • 批准号:
    10452169
  • 财政年份:
    2022
  • 资助金额:
    $ 72.48万
  • 项目类别:
Lupus Omics Cutaneous Kidney Investigative Team (LOCKIT)
狼疮组学皮肤肾研究小组 (LOCKIT)
  • 批准号:
    10596281
  • 财政年份:
    2022
  • 资助金额:
    $ 72.48万
  • 项目类别:
HEALTH: Harnessing Epidemiology to Advance Lupus Treatment and Health
健康:利用流行病学促进狼疮治疗和健康
  • 批准号:
    10552857
  • 财政年份:
    2022
  • 资助金额:
    $ 72.48万
  • 项目类别:
Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)
监测和治疗以预防胎儿房室传导阻滞可能很快发生(STOP BLOQ)
  • 批准号:
    10440476
  • 财政年份:
    2020
  • 资助金额:
    $ 72.48万
  • 项目类别:
Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)
监测和治疗以预防胎儿房室传导阻滞可能很快发生(STOP BLOQ)
  • 批准号:
    10644022
  • 财政年份:
    2020
  • 资助金额:
    $ 72.48万
  • 项目类别:
Mechanisms of DNA-Specific Autoimmunity in Systemic Lupus Erythematosus
系统性红斑狼疮 DNA 特异性自身免疫机制
  • 批准号:
    10374852
  • 财政年份:
    2018
  • 资助金额:
    $ 72.48万
  • 项目类别:
Translational Center of Molecular Profiling in Preclinical and Established Lupus (COMPEL)
临床前和已确诊狼疮分子分析转化中心 (COMPEL)
  • 批准号:
    9766075
  • 财政年份:
    2017
  • 资助金额:
    $ 72.48万
  • 项目类别:

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开发作为抗炎剂和砷解毒剂的小分子抑制剂
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