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临床试验/NCT05961202
NCT05961202招募中2 期

The Efficacy and Mechanism of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy After Myocarditis

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
200
试验地点
1
主要终点
Composite cardiovascular outcome

研究概览

简要总结

Evaluating the long-term therapeutic effects and safety of hydroxychloroquine(compared to glucocorticoid therapy alone) in patients with inflammatory cardiomyopathy--a multicenter randomized controlled study

详细描述

Inflammatory cardiomyopathy is the chronic stage of myocarditis, which is associated with poor cardiovascular outcome and poor prognosis.Inflammatory cardiomyopathy is also one of the common causes of heart failure. Actually, the treatment and prognosis of inflammatory cardiomyopathy remain challenging clinical issues that often have frustrating consequences. So far, there is no specific treatment for inflammatory cardiomyopathy. Hydroxychloroquine is a drug that can effectively inhibit inflammation and has been used in many inflammatory diseases in the past. Our previous basic research has proved that hydroxychloroquine can effectively treat experimental autoimmune myocarditis.Therefore, multicenter large randomized controlled trials are needed to verify the therapeutic effects of hydroxychloroquine on patients with inflammatory cardiomyopathy.

Patients with inflammatory cardiomyopathy after acute myocarditis confirmed by biopsy received standard drug treatment for heart failure. These patients whose cardiac function could not be improved for a long time were randomly assigned (1:1) to hydroxychloroquine group (hydroxychloroquine and glucocorticoid) and glucocorticoid group (glucocorticoid alone). The clinical benefit will be measured with respect to absolute increase in LVEF and decrease in hs-cTnI and NT-proBNP of immunosuppressive treatment with hydroxychloroquine and prednisolone compared to prednisolone alone at long-term follow-up (1, 3, 6, 9, 12, 18, 24, 36 months).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Non-HCQ group

Active Comparator

Prednisolone 20mg qd for 12 months

干预措施: Prednisolone (Drug)

HCQ group

Experimental

Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months

干预措施: Hydroxychloroquine (Drug)

HCQ group

Experimental

Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months

干预措施: Prednisolone (Drug)

结局指标

主要结局

Composite cardiovascular outcome

时间窗: 3 years

The composite cardiovascular outcome of time to cardiovascular death or heart transplant, hospitalization for heart failure or recurrence of myocarditis, permanent pacemaker use, or ICD implantation.

次要结局

  • The decrease and dynamic changes of hs-cTnI (pg/mL)(3 years)
  • The decrease and dynamic changes of NT-proBNP (pg/mL)(3 years)
  • The decrease and dynamic changes of hs-CRP (mg/L)(3 years)
  • The decrease and dynamic changes of ESR (mm/H)(3 years)
  • The increase and dynamic changes of LVEF (%)(3 years)
  • The increase and dynamic changes of LVIDd (mm)(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dao Wen Wang

Prof.

Tongji Hospital

研究点 (1)

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