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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Inflammatory Cardiomyopathy Myocarditis Drug: Hydroxychloroquine Drug: Prednisolone Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Mechanism of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy After Myocarditis
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Arm Intervention/treatment
Experimental: HCQ group
Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for a long time (more than 3 months)
 Drug: Hydroxychloroquine
Hydroxychloroquine 200mg qd

Drug: Prednisolone
Prednisolone 20mg qd
Active Comparator: Non-HCQ group
Prednisolone 20mg qd for a long time (more than 3 months)
 Drug: Prednisolone
Prednisolone 20mg qd


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The increase and dynamic changes of LVEF (%) [ Time Frame: 3 years ]
    Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.

  2. The decrease and dynamic changes of hs-cTnI (pg/mL) [ Time Frame: 3 years ]
  3. The decrease and dynamic changes of NT-proBNP (pg/mL) [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05961202


Contacts
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Contact: Dao Wen Wang, MD, PhD +86-027-6937-8422 dwwang@tjh.tjmu.edu.cn
Contact: Wu He +8613972334305 hewu0912@163.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Dao Wen Wang, MD, PhD    86-27-6937-8422    dwwang@tjh.tjmu.edu.cn   
Contact: Wu He, MD    +8613972334305    hewu0912@163.com   
Sponsors and Collaborators
Tongji Hospital
Wuhan Central Hospital
Taihe Hospital
More Information
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Publications:

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Responsible Party: Dao Wen Wang, Prof., Tongji Hospital
ClinicalTrials.gov Identifier: NCT05961202    
Other Study ID Numbers: TJ-HYPIC
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: June 5, 2024
Last Verified: June 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dao Wen Wang, Tongji Hospital:
Inflammatory cardiomyopathy
Myocarditis
Hydroxychloroquine
Randomized controlled trial
Additional relevant MeSH terms:
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Cardiomyopathies
Myocarditis
Heart Diseases
Cardiovascular Diseases
Hydroxychloroquine
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents