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The Effects of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy (HYPIC)

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ClinicalTrials.gov Identifier: NCT05961202
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : June 5, 2024
Sponsor:
Collaborators:
Wuhan Central Hospital
Taihe Hospital
Information provided by (Responsible Party):
Dao Wen Wang, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE July 18, 2023
First Posted Date  ICMJE July 27, 2023
Last Update Posted Date June 5, 2024
Actual Study Start Date  ICMJE January 1, 2022
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2023)		 Composite incidence of cardiovascular death or heart transplant [ Time Frame: 3 years ]
Cardiovascular death was defined as death from cardiovascular causes and any unknown death unless there was another certain cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2023)
  • The increase and dynamic changes of LVEF (%) [ Time Frame: 3 years ]
    Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.
  • The decrease and dynamic changes of hs-cTnI (pg/mL) [ Time Frame: 3 years ]
  • The decrease and dynamic changes of NT-proBNP (pg/mL) [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy
Official Title  ICMJE The Efficacy and Mechanism of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy After Myocarditis
Brief Summary Evaluating the long-term therapeutic effects of hydroxychloroquine(compared to glucocorticoid therapy alone) in patients with inflammatory cardiomyopathy--a multicenter randomized controlled study
Detailed Description

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 (6, 12, 18, 24, 36 months).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammatory Cardiomyopathy
  • Myocarditis
Intervention  ICMJE
  • Drug: Hydroxychloroquine
    Hydroxychloroquine 200mg qd
  • Drug: Prednisolone
    Prednisolone 20mg qd
Study Arms  ICMJE
  • Experimental: HCQ group
    Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for a long time (more than 3 months)
    Interventions:
    • Drug: Hydroxychloroquine
    • Drug: Prednisolone
  • Active Comparator: Non-HCQ group
    Prednisolone 20mg qd for a long time (more than 3 months)
    Intervention: Drug: Prednisolone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2023)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2025
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-80 years;
  2. Heart failure NYHA II-IV;
  3. Patients with myocarditis confirmed by myocardial biopsy in the past;
  4. Standard treatment for heart failure > 6 months;
  5. Persistent reduction of LVEF <50% on a routine echocardiographic evaluation (Simpson's biplane) not older than 1 month at time of inclusion;
  6. hs-cTnI >26.5pg/mL or NT-proBNP>169 pg/mL；

Exclusion Criteria:

  1. Age <18 or >80 years;
  2. Known or possible systemic inflammatory disease;
  3. Patient on the brink of death or life expectancy<1 year；
  4. Drug or alcohol abuse;
  5. Pregnancy or lactation;
  6. Patients who cannot persist in taking medication due to various reasons;
  7. Inability to provide informed consent;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dao Wen Wang, MD, PhD +86-027-6937-8422 dwwang@tjh.tjmu.edu.cn
Contact: Wu He +8613972334305 hewu0912@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05961202
Other Study ID Numbers  ICMJE TJ-HYPIC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dao Wen Wang, Tongji Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tongji Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Wuhan Central Hospital
  • Taihe Hospital
Investigators  ICMJE Not Provided
PRS Account Tongji Hospital
Verification Date June 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP