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

Primary Purpose

Inflammatory Cardiomyopathy, Myocarditis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hydroxychloroquine
Prednisolone
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Cardiomyopathy focused on measuring Inflammatory cardiomyopathy, Myocarditis, Hydroxychloroquine, Randomized controlled trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80 years; Heart failure NYHA II-IV; Patients with myocarditis confirmed by myocardial biopsy in the past; Standard treatment for heart failure > 6 months; Persistent reduction of LVEF <50% on a routine echocardiographic evaluation (Simpson's biplane) not older than 1 month at time of inclusion; hs-cTnI >26.5pg/mL or NT-proBNP>169 pg/mL; Exclusion Criteria: Age <18 or >80 years; Known or possible systemic inflammatory disease; Patient on the brink of death or life expectancy<1 year; Drug or alcohol abuse; Pregnancy or lactation; Patients who cannot persist in taking medication due to various reasons; Inability to provide informed consent;

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HCQ group

GC group

Arm Description

Hydroxychloroquine 200mg bid and Prednisolone 15mg qd for a long time (more than 1 year)

Prednisolone 15mg qd for a long time (more than 1 year)

Outcomes

Primary Outcome Measures

Composite incidence of cardiovascular death or heart transplant
Cardiovascular death was defined as death from cardiovascular causes and any unknown death unless there was another certain cause.

Secondary Outcome Measures

The increase and dynamic changes of LVEF (%)
Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.
The decrease and dynamic changes of hs-cTnI (pg/mL)
The decrease and dynamic changes of NT-proBNP (pg/mL)

Full Information

First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
Tongji Hospital
Collaborators
Wuhan Central Hospital, Taihe Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05961202
Brief Title
The Effects of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy
Acronym
HYPIC
Official Title
The Efficacy and Mechanism of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy After Myocarditis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
Wuhan Central Hospital, Taihe Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Cardiomyopathy, Myocarditis
Keywords
Inflammatory cardiomyopathy, Myocarditis, Hydroxychloroquine, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HCQ group
Arm Type
Experimental
Arm Description
Hydroxychloroquine 200mg bid and Prednisolone 15mg qd for a long time (more than 1 year)
Arm Title
GC group
Arm Type
Active Comparator
Arm Description
Prednisolone 15mg qd for a long time (more than 1 year)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine 200mg bid
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Prednisolone 15mg qd
Primary Outcome Measure Information:
Title
Composite incidence of cardiovascular death or heart transplant
Description
Cardiovascular death was defined as death from cardiovascular causes and any unknown death unless there was another certain cause.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The increase and dynamic changes of LVEF (%)
Description
Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.
Time Frame
3 years
Title
The decrease and dynamic changes of hs-cTnI (pg/mL)
Time Frame
3 years
Title
The decrease and dynamic changes of NT-proBNP (pg/mL)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years; Heart failure NYHA II-IV; Patients with myocarditis confirmed by myocardial biopsy in the past; Standard treatment for heart failure > 6 months; Persistent reduction of LVEF <50% on a routine echocardiographic evaluation (Simpson's biplane) not older than 1 month at time of inclusion; hs-cTnI >26.5pg/mL or NT-proBNP>169 pg/mL; Exclusion Criteria: Age <18 or >80 years; Known or possible systemic inflammatory disease; Patient on the brink of death or life expectancy<1 year; Drug or alcohol abuse; Pregnancy or lactation; Patients who cannot persist in taking medication due to various reasons; Inability to provide informed consent;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dao Wen Wang, MD, PhD
Phone
+86-027-6937-8422
Email
dwwang@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wu He
Phone
+8613972334305
Email
hewu0912@163.com
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dao Wen Wang, MD, PhD
Phone
86-27-6937-8422
Email
dwwang@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wu He, MD
Phone
+8613972334305
Email
hewu0912@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33303763
Citation
Hang W, Chen C, Seubert JM, Wang DW. Fulminant myocarditis: a comprehensive review from etiology to treatments and outcomes. Signal Transduct Target Ther. 2020 Dec 11;5(1):287. doi: 10.1038/s41392-020-00360-y.
Results Reference
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PubMed Identifier
37002488
Citation
He W, Zhou L, Xu K, Li H, Wang JJ, Chen C, Wang D. Immunopathogenesis and immunomodulatory therapy for myocarditis. Sci China Life Sci. 2023 Sep;66(9):2112-2137. doi: 10.1007/s11427-022-2273-3. Epub 2023 Mar 29.
Results Reference
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The Effects of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy

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