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

July 18, 2023 updated by: Dao Wen Wang, Tongji Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCQ group
Hydroxychloroquine 200mg bid and Prednisolone 15mg qd for a long time (more than 1 year)
Drug: Hydroxychloroquine
Hydroxychloroquine 200mg bid
Drug: Prednisolone
Prednisolone 15mg qd
Active Comparator: GC group
Prednisolone 15mg qd for a long time (more than 1 year)
Drug: Prednisolone
Prednisolone 15mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The increase and dynamic changes of LVEF (%)
Time Frame: 3 years
Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.
3 years
The decrease and dynamic changes of hs-cTnI (pg/mL)
Time Frame: 3 years
3 years
The decrease and dynamic changes of NT-proBNP (pg/mL)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Taihe Hospital
Wuhan Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-HYPIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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